Spinal Anesthesia EvaluationPhase 4NCT06769737
The Prolonging Effect of Dexmedetomidine on Spinal Anesthesia Through Different Routes if Administrations
A Phase 4 study testing Interventional group#1 and Interventional group#2 in people with Spinal Anesthesia Evaluation, run by King Abdulaziz Medical City at 1 site in Saudi Arabia.
Trial summary
This prospective, double-blinded, randomized clinical trial aims to examine the effects of combining isobaric bupivacaine with dexmedetomidine administered intrathecally (IT), compared to the combination of isobaric bupivacaine administered intrathecally and dexmedetomidine administered intravenously (IV), on spinal… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthesia Evaluation
- What is being tested?
- Interventional group#1 and Interventional group#2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Mar 2025to 1 Sep 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female patients in adult age group more than 18 years old
- ASA classification I, II, and III.
- Orthopedic surgery, including total hip replacement (THR) and total knee replacement (TKR).
- No history of Obstructive sleep apnea
Who cannot join
- Patient below 18 years old of both genders.
- ASA classification of IV and more.
- Patients with a height of less than 150 cm.
- Patients on alpha-two antagonist ACE inhibitors and CCB.
- Patient received intrathecal morphine, intravascular dexamethasone, or Midazolam
- Patient who can't tolerate fluid challenge. Example: ESRD, HF…etc.
- Any contraindication for neuraxial procedure. Examples: coagulopathy, severe AS, sepsis…etc.
- Psychiatric patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
King Abdulaziz Medical City
Riyadh, 11551
Heba Musalem, 0533112656, hebamusallam91@gmail.com
About this study
Official title: The Prolonged Effects of Spinal Dexmedetomidine Versus Intravenous Dexmedetomidine on Spinal Anesthesia With Isobaric Bupivacaine: A Comparative Study
This prospective, double-blinded, randomized clinical trial aims to examine the effects of combining isobaric bupivacaine with dexmedetomidine administered intrathecally (IT), compared to the combination of isobaric bupivacaine administered intrathecally and dexmedetomidine administered intravenously (IV), on spinal anesthesia prolongation time in minutes, time of regression from Bromage score 3 to 0.
Read the detailed description
Dexmedetomidine, an α2-adrenergic agonist, is commonly used in anesthetic practice for various applications, including premedication, as an adjunct to general anesthesia, sole anesthetic agent, and sedation in intensive care settings. Its effects include enhancing the efficacy of other anesthetic drugs, inducing perioperative sympatholysis, and lowering blood pressure by stimulating central α2 and imidazoline receptors.
Spinal anesthesia is a type of regional anesthesia that involves administering a local anesthetic directly into the cerebrospinal fluid surrounding the spinal cord and nerve roots. It is primarily used for procedures below the umbilicus, such as orthopedic surgeries involving joints and bones.
The 0.5% isobaric formulation of bupivacaine is characterized by a slower onset compared to hyperbaric formulations but provides a longer duration of both sensory and motor blockade. Achieving successful spinal anesthesia (SA) depends on selecting the appropriate dose of isobaric bupivacaine. Administering an excessive dose can lead to high spinal anesthesia, while an insufficient dose may result in inadequate cephalad spread.
A retrospective observational study involving 1,079 adult patients who received spinal anesthesia with 0.5% isobaric bupivacaine between 2018 and 2021 investigated the relationship between the bupivacaine dose and block height. The study concluded that for patients younger than 60 years, doses of 15-17 mg (3.0-3.4 mL) were optimal, while doses of 10.5-16 mg (2.1-3.2 mL) were suitable for patients aged 60 years or older. These doses achieved a T5-T10
Over the years, various agents have been combined with local anesthetics (LA) to extend the duration of action in both spinal anesthesia via intrathecal (IT) administration and peripheral nerve blocks (PNB), achieving varying levels of success. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, offers several advantages as an adjuvant. These include its sedative and analgesic effects (acting at both spinal and supraspinal levels), anti-anxiety properties, inhibition of sympathetic activity, mild respiratory depression, and hemodynamic stability.
Intrathecal α2-adrenergic receptor agonists, including dexmedetomidine, have been shown to exhibit antinociceptive properties for both somatic and visceral pain. Studies using small doses of intrathecal dexmedetomidine (e.g., 3 µg) in combination with bupivacaine for spinal anesthesia demonstrated faster motor block onset, prolonged motor as well as sensory block durations, and preserved hemodynamic stability without causing significant sedation.
The dose-dependent effects of dexmedetomidine have been extensively studied. Randomized clinical trials (RCTs) comparing doses (e.g., 3 µg vs. 5 µg with isobaric Ropivacaine and 5 µg vs. 10 µg with isobaric bupivacaine) consistently concluded that higher doses of dexmedetomidine enhanced the onset and prolonged the duration of sensory and motor block when used as an adjuvant in spinal anesthesia.
Intravenous dexmedetomidine has also been shown to prolong the sensory and motor block of bupivacaine through its supraspinal anesthetic and analgesic actions. However, its intravenous administration is associated with a dose-dependent risk of bradycardia. A systematic review and meta-analysis conducted in 2013, which included 364 patients from seven randomized controlled trials of intermediate to high quality, examined the effects of intravenous dexmedetomidine on spinal anesthesia duration. The analysis found that motor block duration increased by approximately 21% (P < 0.00001). Importantly, no significant differences in the incidence of hypotension or postoperative sedation were observed between the dexmedetomidine and placebo groups, and none of the patients experienced respiratory depression.
- Conditions
- Spinal Anesthesia Evaluation
- Being tested
- Interventional group#1, Interventional group#2
- Keywords
- dexmedetomedine, intrathecal dexmedetomedine, intravenous dexmedetomedine, spinal anesthesia prolongation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional group#1Drug
Also called Intrathecal "Dexmedetomidine HCL," "Demexa®,"
The intrathecal mixture of spinal anesthesia: 12 mg of isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) + 20 mcg of "Fentanyl," "Martindale pharma Fentanyl®," 50mcg/ml (0.4ml) + 3 mcg of "Dexmedetomidine HCL," "Demexa®," 4mcg/ml (0.75 ml) total volume = 3.55 ml.
The Bromage score will be assessed by the anesthesiologist every 5 minutes after positioning the patient supine until the first incision. The Bromage score is a clinical scale used to determine motor block during regional anesthesia by evaluating lower limb movement: Grade 0: Full movement of hips, knees, and ankles (no block). Grade 1: Unable to lift the leg but can move knees and ankles (partial block). Grade 2: Unable to bend the knee but can move ankles (near-complete block). Grade 3: No movement in hips, knees, or ankles (complete block). Dermatomal coverage will be assessed simultaneously till it reaches the L1-L2 level. Also, The Ramsay Sedation Scale (RSS) will be used to evaluate the sedation depth, if any.
Interventional group#2Drug
Also called Intravascular "Dexmedetomidine HCL," "Demexa®,"
The intrathecal mixture of spinal anesthesia: 12 mg of isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) + 20 mcg of "Fentanyl," "Martindale pharma Fentanyl®," 50mcg/ml (0.4ml) total volume = 2.8 ml.
The intravascular mixture consists of 0.5 mcg/kg of "Dexmedetomidine HCL," "Demexa®," and a maximum of 30 mcg diluted to 4 mcg/ml. According to body weight, the total volume is 7.5 ml or less and given using a syringe pump over 30 minutes. The anesthesiologist will start the infusion once the patient is positioned supine post-spinal anesthesia and has stable hemodynamics. The Bromage score will be assessed by the anesthesiologist every 5 minutes after positioning the patient supine until the first incision reaches grade 3: No movement in hips, knees, or ankles (complete block). The anesthesiologist will assess dermatomal coverage until it reaches the L1-L2 and calculate the Ramsay Sedation Scale (RSS) of the depth of sedation aiming for level 2: Patient is cooperative, oriented, and calm
| Study group | Role | What they receive |
|---|---|---|
| Controlled | No intervention | Group A: Control group. Receiving plain isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) + 0.15 ml of normal saline (placebo), total volume = 2.4 ml. Through IV, 15 ml of normal saline ( placebo) will be received over 30 mins. |
| Dexmedetomidine HCL IT | Experimental | Group B: RECEIVING IT "Dexmedetomidine HCL," "Demexa®," Through IT, receiving plain isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) +3mcg of "Dexmedetomidine HCL, (0.15 ml), total volume = 2.4 ml.
Through IV, 15 ml of normal saline ( placebo) will be received over 30 mins. Receives: Drug: Interventional group#1 |
| Dexmedetomidine HCL IV | Experimental | Group C: RECEIVING IV "Dexmedetomidine HCL," "Demexa®,"
Through IT, receiving plain isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) + Placebo of normal saline (0.15 ml), total volume = 2.4 ml.
Through IV, 0.5 mcg/kg of "Dexmedetomidine HCL" is prepared in a concentration of 2 mcg/ml ( maximum of 15 ml, 30 mcg) over 30 mins. Receives: Drug: Interventional group#2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression time of Bromage score from 3 to 0
This double-blind study will include 75 participants divided equally into three groups: A, B, and C. The IT medication injection / IV infusion start time is considered time zero. The Bromage score will be assessed at the motor block's onset, representing a Bromage score of 3, recorded in minutes. The record of the time to reach Bromage 3 represents the spinal anesthesia's onset time.
The Bromage scale is a clinical scale used to determine motor block during regional anesthesia. It evaluates lower limb movement, grade 0, no motor block, to grade 3, complete motor block.
Bromage 0; the patient can move hip, knee, and ankle. No motor block Bromage 1: the patient cannot move the hip but can move the knee and ankle. Partial block Bromage 2: the patient cannot move the hip and knee but can move the ankle. partial block Bromage 3: the patient cannot move the hip, knee, and ankle. Complete motor block A Bronage score regression to 0 during a PACU stay will represent a spinal anesthesia offset
Measured: Patients' recruitment and participation in the study will be over 3-4 month, as the load of lower limb surgery at KAMC is high. Subjects' participation will be throughout the surgery time and 45 mins later in PACU if there was not a reason for delay.
Secondary outcomes (2)
Hypotension, bradycardia and desaturation with dermatome coverage <T4 or >T4, checked by Ice test.
Investigators will monitor the side effects associated with each route of administration through close hemodynamic monitoring for heart rate (HR) in Beat per minute (BPM), Oxygen saturation (SpO2) presented in percentage (%), and blood pressure (BP) presented in millimeter mercury (mmHg), aiming for HR above 50 bpm, oxygen saturation >94%, and BP 15% around the patient's baseline blood pressure. All data will be recorded on the data collection sheet.
To differentiate high spinal-related hemodynamic instability ( dermatome >4) versus dexmedetomidine (dermatome less than T4), the sensory block level will be checked with an ICE test, where the dermatomal coverage will be checked along the midaxillary line with an ice bag, as nipple line is representing dermatome T4.
HR limits: 60 to 100 bpm. Lower bradycardia, higher tachycardia. BP limits, systolic 100 - 120 mmHg. Lower hypotension, higher hypertension. SpO2 limit: 100-94%, 100% standard, <94% desaturation.
Measured: Patients' recruitment and participation in the study will be over 3-4 month, as the load of lower limb surgery at KAMC is high. Subjects' participation will be throughout the surgery time and 45 mins later in PACU if there was not a reason for delay.
Sedation score using Ramsay sedation score, aiming for score 2; calm and oriented.
The Investigators will check the Ramsay Sedation Scale (RSS) throughout the procedure. It is used to evaluate the depth of sedation in patients and divided into six scales (from scale no.1, anxious to scale no.6, no response), aiming for scale no.2: cooperative, oriented, and calm. All data will be recorded on the data collection sheet every 10 minutes for the first hour of "Dexmedetomidine" administration and 45 minutes in PACU.
The scale is getting worse while the moving up in the scale Score 1: anxious, agitated, and restless. Score 2: Cooperative-oriented and tranquil. Score 3: The patient responds to commands only. Score 4: The patient responds to a brisk response to a light glabellar tap or loud auditory stimulation.
Score 5: Patient sluggishly responds to a light glabellar tap or loud auditory stimulus.
Score 6: The patient exhibits no response.
Measured: Patients' recruitment and participation in the study will be over 3-4 month, as the load of lower limb surgery at KAMC is high. Subjects' participation will be throughout the surgery time and 45 mins later in PACU if there was not a reason for delay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion15 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Spinal Anesthesia EvaluationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective, single-blinded, randomized clinical trial compares the effects of intrathecal (IT) dexmedetomidine combined with isobaric bupivacaine and intravenous (IV) dexmedetomidine combined with intrathecal isobaric bupivacaine on the duration of spinal anesthesia. The study includes one control group and two interventional groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz Medical City
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hebah Musalem, King Abdulaziz Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769737
- Sponsor's protocol ID
- ICTR24/001/11
- Status last verified
- Jan 2025
- First submitted
- 2 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data interpretation, analysis, and results
Publications
Abdallah FW, Abrishami A, Brull R. The facilitatory effects of intravenous dexmedetomidine on the duration of spinal anesthesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jul;117(1):271-8. doi: 10.1213/ANE.0b013e318290c566. Epub 2013 Apr 30.
PubMed 23632057Kaya FN, Yavascaoglu B, Turker G, Yildirim A, Gurbet A, Mogol EB, Ozcan B. Intravenous dexmedetomidine, but not midazolam, prolongs bupivacaine spinal anesthesia. Can J Anaesth. 2010 Jan;57(1):39-45. doi: 10.1007/s12630-009-9231-6. Epub 2009 Dec 29.
PubMed 20039221Al-Mustafa MM, Abu-Halaweh SA, Aloweidi AS, Murshidi MM, Ammari BA, Awwad ZM, Al-Edwan GM, Ramsay MA. Effect of dexmedetomidine added to spinal bupivacaine for urological procedures. Saudi Med J. 2009 Mar;30(3):365-70.
PubMed 19271064Kanazi GE, Aouad MT, Jabbour-Khoury SI, Al Jazzar MD, Alameddine MM, Al-Yaman R, Bulbul M, Baraka AS. Effect of low-dose dexmedetomidine or clonidine on the characteristics of bupivacaine spinal block. Acta Anaesthesiol Scand. 2006 Feb;50(2):222-7. doi: 10.1111/j.1399-6576.2006.00919.x.
PubMed 16430546Lundblad M, Trifa M, Kaabachi O, Ben Khalifa S, Fekih Hassen A, Engelhardt T, Eksborg S, Lonnqvist PA. Alpha-2 adrenoceptor agonists as adjuncts to peripheral nerve blocks in children: a meta-analysis. Paediatr Anaesth. 2016 Mar;26(3):232-8. doi: 10.1111/pan.12825. Epub 2015 Dec 16.
PubMed 26671834Visavakul O, Leurcharusmee P, Pipanmekaporn T, Khorana J, Patumanond J, Phinyo P. Effective Dose Range of Intrathecal Isobaric Bupivacaine to Achieve T5-T10 Sensory Block Heights for Elderly and Overweight Patients: An Observational Study. Medicina (Kaunas). 2023 Mar 1;59(3):484. doi: 10.3390/medicina59030484.
PubMed 36984485Uppal V, Retter S, Shanthanna H, Prabhakar C, McKeen DM. Hyperbaric Versus Isobaric Bupivacaine for Spinal Anesthesia: Systematic Review and Meta-analysis for Adult Patients Undergoing Noncesarean Delivery Surgery. Anesth Analg. 2017 Nov;125(5):1627-1637. doi: 10.1213/ANE.0000000000002254.
PubMed 28708665Taye MG, Molla A, Teshome D, Hunie M, Kibret S, Fentie Y, Temesgen N, Engidaw MT, Fenta E. Predictors of hypoxemia after general anesthesia in the early postoperative period in a hospital in Ethiopia: an observational study. Multidiscip Respir Med. 2021 Dec 1;16(1):782. doi: 10.4081/mrm.2021.782. eCollection 2021 Jan 15.
PubMed 35003732Bekker AY, Kaufman B, Samir H, Doyle W. The use of dexmedetomidine infusion for awake craniotomy. Anesth Analg. 2001 May;92(5):1251-3. doi: 10.1097/00000539-200105000-00031. No abstract available.
PubMed 11323355Khan ZP, Ferguson CN, Jones RM. alpha-2 and imidazoline receptor agonists. Their pharmacology and therapeutic role. Anaesthesia. 1999 Feb;54(2):146-65. doi: 10.1046/j.1365-2044.1999.00659.x.
PubMed 10215710
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prolonged Effects of Spinal Dexmedetomidine Versus Intravenous Dexmedetomidine on Spinal Anesthesia With Isobaric Bupivacaine: A Comparative Study
- ClinicalTrials.gov ID
- NCT06769737
- Acronym / sponsor ID
- ICTR24/001/11
- Conditions
- Spinal Anesthesia Evaluation
- Keywords
- dexmedetomedine, intrathecal dexmedetomedine, intravenous dexmedetomedine, spinal anesthesia prolongation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- King Abdulaziz Medical CityOther government
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, double-blinded, randomized clinical trial aims to examine the effects of combining isobaric bupivacaine with dexmedetomidine administered intrathecally (IT), compared to the combination of isobaric bupivacaine administered intrathecally and dexmedetomidine administered intravenously (IV), on spinal anesthesia prolongation time in minutes, time of regression from Bromage score 3 to 0.
Detailed description
Dexmedetomidine, an α2-adrenergic agonist, is commonly used in anesthetic practice for various applications, including premedication, as an adjunct to general anesthesia, sole anesthetic agent, and sedation in intensive care settings. Its effects include enhancing the efficacy of other anesthetic drugs, inducing perioperative sympatholysis, and lowering blood pressure by stimulating central α2 and imidazoline receptors.
Spinal anesthesia is a type of regional anesthesia that involves administering a local anesthetic directly into the cerebrospinal fluid surrounding the spinal cord and nerve roots. It is primarily used for procedures below the umbilicus, such as orthopedic surgeries involving joints and bones.
The 0.5% isobaric formulation of bupivacaine is characterized by a slower onset compared to hyperbaric formulations but provides a longer duration of both sensory and motor blockade. Achieving successful spinal anesthesia (SA) depends on selecting the appropriate dose of isobaric bupivacaine. Administering an excessive dose can lead to high spinal anesthesia, while an insufficient dose may result in inadequate cephalad spread.
A retrospective observational study involving 1,079 adult patients who received spinal anesthesia with 0.5% isobaric bupivacaine between 2018 and 2021 investigated the relationship between the bupivacaine dose and block height. The study concluded that for patients younger than 60 years, doses of 15-17 mg (3.0-3.4 mL) were optimal, while doses of 10.5-16 mg (2.1-3.2 mL) were suitable for patients aged 60 years or older. These doses achieved a T5-T10
Over the years, various agents have been combined with local anesthetics (LA) to extend the duration of action in both spinal anesthesia via intrathecal (IT) administration and peripheral nerve blocks (PNB), achieving varying levels of success. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, offers several advantages as an adjuvant. These include its sedative and analgesic effects (acting at both spinal and supraspinal levels), anti-anxiety properties, inhibition of sympathetic activity, mild respiratory depression, and hemodynamic stability.
Intrathecal α2-adrenergic receptor agonists, including dexmedetomidine, have been shown to exhibit antinociceptive properties for both somatic and visceral pain. Studies using small doses of intrathecal dexmedetomidine (e.g., 3 µg) in combination with bupivacaine for spinal anesthesia demonstrated faster motor block onset, prolonged motor as well as sensory block durations, and preserved hemodynamic stability without causing significant sedation.
The dose-dependent effects of dexmedetomidine have been extensively studied. Randomized clinical trials (RCTs) comparing doses (e.g., 3 µg vs. 5 µg with isobaric Ropivacaine and 5 µg vs. 10 µg with isobaric bupivacaine) consistently concluded that higher doses of dexmedetomidine enhanced the onset and prolonged the duration of sensory and motor block when used as an adjuvant in spinal anesthesia.
Intravenous dexmedetomidine has also been shown to prolong the sensory and motor block of bupivacaine through its supraspinal anesthetic and analgesic actions. However, its intravenous administration is associated with a dose-dependent risk of bradycardia. A systematic review and meta-analysis conducted in 2013, which included 364 patients from seven randomized controlled trials of intermediate to high quality, examined the effects of intravenous dexmedetomidine on spinal anesthesia duration. The analysis found that motor block duration increased by approximately 21% (P < 0.00001). Importantly, no significant differences in the incidence of hypotension or postoperative sedation were observed between the dexmedetomidine and placebo groups, and none of the patients experienced respiratory depression.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This prospective, single-blinded, randomized clinical trial compares the effects of intrathecal (IT) dexmedetomidine combined with isobaric bupivacaine and intravenous (IV) dexmedetomidine combined with intrathecal isobaric bupivacaine on the duration of spinal anesthesia. The study includes one control group and two interventional groups.
| Arm | Type | Receives |
|---|---|---|
| Controlled | No intervention | –Group A: Control group. Receiving plain isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) + 0.15 ml of normal saline (placebo), total volume = 2.4 ml. Through IV, 15 ml of normal saline ( placebo) will be received over 30 mins. |
| Dexmedetomidine HCL IT | Experimental | Drug: Interventional group#1Group B: RECEIVING IT "Dexmedetomidine HCL," "Demexa®," Through IT, receiving plain isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) +3mcg of "Dexmedetomidine HCL, (0.15 ml), total volume = 2.4 ml. Through IV, 15 ml of normal saline ( placebo) will be received over 30 mins. |
| Dexmedetomidine HCL IV | Experimental | Drug: Interventional group#2Group C: RECEIVING IV "Dexmedetomidine HCL," "Demexa®," Through IT, receiving plain isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) + Placebo of normal saline (0.15 ml), total volume = 2.4 ml. Through IV, 0.5 mcg/kg of "Dexmedetomidine HCL" is prepared in a concentration of 2 mcg/ml ( maximum of 15 ml, 30 mcg) over 30 mins. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients in adult age group more than 18 years old
- ASA classification I, II, and III.
- Orthopedic surgery, including total hip replacement (THR) and total knee replacement (TKR).
- No history of Obstructive sleep apnea
Key exclusion criteria (8 listed)
- Patient below 18 years old of both genders.
- ASA classification of IV and more.
- Patients with a height of less than 150 cm.
- Patients on alpha-two antagonist ACE inhibitors and CCB.
- Patient received intrathecal morphine, intravascular dexamethasone, or Midazolam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventional group#1Also: Intrathecal "Dexmedetomidine HCL," "Demexa®,"The intrathecal mixture of spinal anesthesia: 12 mg of isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) + 20 mcg of "Fentanyl," "Martindale pharma Fentanyl®," 50mcg/ml (0.4ml) + 3 mcg of "Dexmedetomidine HCL," "Demexa®," 4mcg/ml (0.75 ml) total volume = 3.55 ml. The Bromage score will be assessed by the anesthesiologist every 5 minutes after positioning the patient supine until the first incision. The Bromage score is a clinical scale used to determine motor block during regional anesthesia by evaluating lower limb movement: Grade 0: Full movement of hips, knees, and ankles (no block). Grade 1: Unable to lift the leg but can move knees and ankles (partial block). Grade 2: Unable to bend the knee but can move ankles (near-complete block). Grade 3: No movement in hips, knees, or ankles (complete block). Dermatomal coverage will be assessed simultaneously till it reaches the L1-L2 level. Also, The Ramsay Sedation Scale (RSS) will be used to evaluate the sedation depth, if any. | Drug | Dexmedetomidine HCL IT |
| Interventional group#2Also: Intravascular "Dexmedetomidine HCL," "Demexa®,"The intrathecal mixture of spinal anesthesia: 12 mg of isobaric "Bupivacaine 0.5%", "Bucaine®," (2.4 ml) + 20 mcg of "Fentanyl," "Martindale pharma Fentanyl®," 50mcg/ml (0.4ml) total volume = 2.8 ml. The intravascular mixture consists of 0.5 mcg/kg of "Dexmedetomidine HCL," "Demexa®," and a maximum of 30 mcg diluted to 4 mcg/ml. According to body weight, the total volume is 7.5 ml or less and given using a syringe pump over 30 minutes. The anesthesiologist will start the infusion once the patient is positioned supine post-spinal anesthesia and has stable hemodynamics. The Bromage score will be assessed by the anesthesiologist every 5 minutes after positioning the patient supine until the first incision reaches grade 3: No movement in hips, knees, or ankles (complete block). The anesthesiologist will assess dermatomal coverage until it reaches the L1-L2 and calculate the Ramsay Sedation Scale (RSS) of the depth of sedation aiming for level 2: Patient is cooperative, oriented, and calm | Drug | Dexmedetomidine HCL IV |
Primary outcome
Regression time of Bromage score from 3 to 0
Time frame: Patients' recruitment and participation in the study will be over 3-4 month, as the load of lower limb surgery at KAMC is high. Subjects' participation will be throughout the surgery time and 45 mins later in PACU if there was not a reason for delay.
This double-blind study will include 75 participants divided equally into three groups: A, B, and C. The IT medication injection / IV infusion start time is considered time zero. The Bromage score will be assessed at the motor block's onset, representing a Bromage score of 3, recorded in minutes. The record of the time to reach Bromage 3 represents the spinal anesthesia's onset time. The Bromage scale is a clinical scale used to determine motor block during regional anesthesia. It evaluates lower limb movement, grade 0, no motor block, to grade 3, complete motor block. Bromage 0; the patient can move hip, knee, and ankle. No motor block Bromage 1: the patient cannot move the hip but can move the knee and ankle. Partial block Bromage 2: the patient cannot move the hip and knee but can move the ankle. partial block Bromage 3: the patient cannot move the hip, knee, and ankle. Complete motor block A Bronage score regression to 0 during a PACU stay will represent a spinal anesthesia offset
2 secondary outcomes
Hypotension, bradycardia and desaturation with dermatome coverage <T4 or >T4, checked by Ice test.
Time frame: Patients' recruitment and participation in the study will be over 3-4 month, as the load of lower limb surgery at KAMC is high. Subjects' participation will be throughout the surgery time and 45 mins later in PACU if there was not a reason for delay.
Sedation score using Ramsay sedation score, aiming for score 2; calm and oriented.
Time frame: Patients' recruitment and participation in the study will be over 3-4 month, as the load of lower limb surgery at KAMC is high. Subjects' participation will be throughout the surgery time and 45 mins later in PACU if there was not a reason for delay.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Background: PubMed 23632057Abdallah FW, Abrishami A, Brull R. The facilitatory effects of intravenous dexmedetomidine on the duration of spinal anesthesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jul;117(1):271-8. doi: 10.1213/ANE.0b013e318290c566. Epub 2013 Apr 30.
- Background: PubMed 20039221Kaya FN, Yavascaoglu B, Turker G, Yildirim A, Gurbet A, Mogol EB, Ozcan B. Intravenous dexmedetomidine, but not midazolam, prolongs bupivacaine spinal anesthesia. Can J Anaesth. 2010 Jan;57(1):39-45. doi: 10.1007/s12630-009-9231-6. Epub 2009 Dec 29.
- Background: PubMed 19271064Al-Mustafa MM, Abu-Halaweh SA, Aloweidi AS, Murshidi MM, Ammari BA, Awwad ZM, Al-Edwan GM, Ramsay MA. Effect of dexmedetomidine added to spinal bupivacaine for urological procedures. Saudi Med J. 2009 Mar;30(3):365-70.
- Background: PubMed 16430546Kanazi GE, Aouad MT, Jabbour-Khoury SI, Al Jazzar MD, Alameddine MM, Al-Yaman R, Bulbul M, Baraka AS. Effect of low-dose dexmedetomidine or clonidine on the characteristics of bupivacaine spinal block. Acta Anaesthesiol Scand. 2006 Feb;50(2):222-7. doi: 10.1111/j.1399-6576.2006.00919.x.
- Background: PubMed 26671834Lundblad M, Trifa M, Kaabachi O, Ben Khalifa S, Fekih Hassen A, Engelhardt T, Eksborg S, Lonnqvist PA. Alpha-2 adrenoceptor agonists as adjuncts to peripheral nerve blocks in children: a meta-analysis. Paediatr Anaesth. 2016 Mar;26(3):232-8. doi: 10.1111/pan.12825. Epub 2015 Dec 16.
- Background: PubMed 36984485Visavakul O, Leurcharusmee P, Pipanmekaporn T, Khorana J, Patumanond J, Phinyo P. Effective Dose Range of Intrathecal Isobaric Bupivacaine to Achieve T5-T10 Sensory Block Heights for Elderly and Overweight Patients: An Observational Study. Medicina (Kaunas). 2023 Mar 1;59(3):484. doi: 10.3390/medicina59030484.
- Background: PubMed 28708665Uppal V, Retter S, Shanthanna H, Prabhakar C, McKeen DM. Hyperbaric Versus Isobaric Bupivacaine for Spinal Anesthesia: Systematic Review and Meta-analysis for Adult Patients Undergoing Noncesarean Delivery Surgery. Anesth Analg. 2017 Nov;125(5):1627-1637. doi: 10.1213/ANE.0000000000002254.
- Background: PubMed 35003732Taye MG, Molla A, Teshome D, Hunie M, Kibret S, Fentie Y, Temesgen N, Engidaw MT, Fenta E. Predictors of hypoxemia after general anesthesia in the early postoperative period in a hospital in Ethiopia: an observational study. Multidiscip Respir Med. 2021 Dec 1;16(1):782. doi: 10.4081/mrm.2021.782. eCollection 2021 Jan 15.
- Background: PubMed 11323355Bekker AY, Kaufman B, Samir H, Doyle W. The use of dexmedetomidine infusion for awake craniotomy. Anesth Analg. 2001 May;92(5):1251-3. doi: 10.1097/00000539-200105000-00031. No abstract available.
- Background: PubMed 10215710Khan ZP, Ferguson CN, Jones RM. alpha-2 and imidazoline receptor agonists. Their pharmacology and therapeutic role. Anaesthesia. 1999 Feb;54(2):146-65. doi: 10.1046/j.1365-2044.1999.00659.x.
- Individual participant dataSharing planned: Yes. Data interpretation, analysis, and results
Related trials for Spinal Anesthesia Evaluation
RecruitingObservational study
Patient Experiences of Intraoperative Discomfort During Cesarean Delivery Under Neuraxial Anesthesia
Discomfort, Psychological Well Being
Recruiting
Evaluation and Comparison Between General Anesthesia VS Two Types of Combined Anesthesia for Opioid Consumption in Laparoscopic Hysterectomy
Laparoscopic Hysterectomy, Gynecology
Not yet recruitingPhase 2/3
Intrathecal Dexmedetomidine and Postoperative Delirium in Elderly Hip Fracture Surgery
Postoperative Delirium, Hip Fractures
Not yet recruitingObservational study
An Observational Study Measuring in a Non-invasive Approach the Nociception Level Index and Its Association With Pain and Anxieiy Perception Evaluated by Questionnaires, in Awake Women During Elective Cesarean Delivery Under Spinal Anesthesiaanxiety
Cesarean Delivery
Active, not recruitingObservational study
Evaluation of Postoperative Hearing Loss After Spinal Anesthesia for Elective Cesarean Section in Pregnant Women
Hearing Loss; Post-Dural Puncture Headache; Cesarean Delivery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Interventional group#1 and Interventional group#2 in people with Spinal Anesthesia Evaluation, run by King Abdulaziz Medical City at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hebah Musalem, Anesthesia Asistant consultant (00966533112656, hebamusallam91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression time of Bromage score from 3 to 0 (time frame: Patients' recruitment and participation in the study will be over 3-4 month, as the load of lower limb surgery at KAMC is high. Subjects' participation will be throughout the surgery time and 45 mins later in PACU if there was not a reason for delay.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06769737, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.