Postoperative PainPhase 4NCT07035223
Clinical Comparative Study Aiming to Evaluate Postoperative Effect of Using Intrathecal Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Lower Limb Vascular Surgeries on Pain Intensity, Analgesic Requirement and Shivering. Patients and Methods After Approval of Medical Institution
A Phase 4 study testing 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-fr and fentanyl in people with Postoperative Pain, run by Nashwa Ahmed at 1 site in Egypt.
Trial summary
Spinal anaesthesia is an excellent choice of numerous operating procedures. This is due to its effectiveness, rapid onset of action, easy to implement, patient stayed awake, and minimal drug cost.(1) It is also beneficial for patients with chronic airway disorders, reducing the risk of pulmonary aspiration and… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-fr and fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Apr 2025to 30 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient aged range from 20 to 60 years
- ASA 1 and 2
- Patient prepared for elective lower limb surgeries.
- Either sex male or female.
Who cannot join
- 1- Patient refusal. 2- Patient has absolute contraindication to spinal anaesthesia. 3- Patients with ASA 3 or more 4- Patients taking ACE inhibitor, adrenergic receptor antagonist and calcium channel blocker.
- 5-Patients with head injury and polytrauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Postoperative Effect Dexmedetomidine or Fentanyl as an Adjuvant to Heavy Bupivacaine in Spinal Anaesthesia in Lower Limb Vascular Surgeries
Spinal anaesthesia is an excellent choice of numerous operating procedures. This is due to its effectiveness, rapid onset of action, easy to implement, patient stayed awake, and minimal drug cost.(1) It is also beneficial for patients with chronic airway disorders, reducing the risk of pulmonary aspiration and vomiting in patients with full stomach, as well as its fewer adverse effects, and speedy patient turnover. (2,1) In lower abdominal and lower limb surgeries, spinal anaesthesia is still the primary option. (3) The resultant nerve block is sufficient for patient welfare, while motor block eases the surgeon's work. Moreover, it grants efficient pain relief in the early post-operative period. (2) Yet, postoperative analgesia is a most important dilemma. (4) Thus, additional pain control is essential after spinal anaesthesia effect fades. Consequently, effective analgesia is crucial to accelerate rehabilitation and return to proper functional ability. Post-operative analgesia can be accomplished by numerous approaches specifically systemic opioid and non-opioid, local wound infiltration and peripheral nerve blocks, each approach have its own advantages and drawbacks.
Read the detailed description
Different adjuvants have been added to local anaesthetics in spinal anaesthesia such as adrenaline, midazolam, clonidine, neostigmine, magnesium, and ketamine to extend the analgesic effect duration and to decrease the prevalence of adverse actions, but no one had been reputable in daily clinical practice. (2,4,5) Administration of opioids intrathecal such as fentanyl, morphine, and buprenorphine, allows decrease dose of the local anesthetic drug, augment analgesic effectiveness, and reduces probable toxicity and cardiovascular adverse consequences of local anesthetics. (5,6) Dexmedetomidine is a novel central alpha2-agonist that was approved by the FDA in 1999.It has sedation, anxiolytic, analgesic and sympatholytic effect that depress cardiovascular reflexes in perioperative interval. (6) Thus, this study will be conducted for assessment of the effectiveness of addition 4 µg Dexmedetomidine to hyperbaric Bupivacaine intrathecally in lower limb surgeries.
Aim This clinical comparative study aiming to evaluate postoperative effect of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb surgeries on pain intensity, analgesic requirement and shivering.
Patients and Methods After approval of medical institutional ethical committee, 40 patients of American Society of Anaesthesiologists (ASA) physical status 1or 2, aged between 20-60 years will be incorporated in this prospective randomized controlled study.
Inclusion Criteria
1- The patient aged range from 20 to 60 years 2- ASA 1 and 2 3- Patient prepared for elective lower limb surgeries. 4- Either sex male or female. Exclusion Criteria
- Patient refusal.
- Patient has absolute contraindication to spinal anaesthesia.
- Patients with ASA 3 or more
- Patients taking ACE inhibitor, adrenergic receptor antagonist and calcium channel blocker.
- Patients with head injury and polytrauma.
An informed written consent will be taken from all the providers. Patients will be divided into the following groups using randomizer software. Group D: patients will receive 3 mL volume of 0.5% hyperbaric bupivacaine and 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-free normal saline, 0.5 ml will be withdrawn) Group F: patients will receive 3 mL volume of 0.5% hyperbaric bupivacaine with 25 µg fentanyl (0.5 mL) intrathecal.
In preoperative room area: clinical history and examination will be evaluated, and then non-invasive BP and heart rate will be measured and recorded as baseline values.
Technique and measurement
- Patients will be moved to operation table, 18G IV access is inserted and secured.
- Preloading begin15minutes before spinal anaesthesia administration with ringer lactated 20ml /kg.
- Intraoperative monitoring involves NIBP, pulse rate, ECG, SPO2
- Patients are divided randomly into two groups by using randomizer software.
- Baseline vital signs will be measured.
- Under strict aseptic technique, after the local infiltration with 2% lignocaine, lumbar puncture is done using 25 G Quincke spinal needle, at L 3 - L 4 space after free flow of csf is verified. Instantly after spinal injection, the patient is placed in a supine position with a cushion supporting shoulders and head. O2 (4-6L/min) is provided throughout face mask.
Post-operative measurement will be collected from instant recovery room to time of the first analgesia dose administrated in the ward Pain will be assessed firstly every 1 hour for first 4 hours and subsequently till the patient required analgesia by means of "Visual Analogue Scale", It is lined scale, entails a 10 cm line attached at one end by a marker such as "No pain" and the other end by "Worst pain comprehendible". Patient just make mark on the line to denote the intensity of pain. (6) First analgesic requirement time is defined as from the time of spinal injection to the time the patient requires analgesia. The rescue analgesic used is Tramadol 50mg IV for visual analogue score of more than 4.
The incidence and intensity of shivering will be also assessed postoperatively in the recovery room using the method of Tsai and Chu as follows: (5) 0, no shivering
- peripheral vasoconstriction without visible shivering
- muscular activity in only one muscle group
- muscular activity in more than one muscle group
- shivering involving the whole body.
- Conditions
- Postoperative Pain
- Being tested
- 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-fr, fentanyl
- Keywords
- fentanyl, bupivacaine, spinal anaesthesia, vascular, dexmedetomidine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-frDrug
Group D: patients will receive 3 mL volume of 0.5% hyperbaric bupivacaine and 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-free normal saline, 0.5 ml will be withdrawn)
fentanylDrug
Group F:patients will receive 3 mL volume of 0.5% hyperbaric bupivacaine with 25 µg fentanyl (0.5 mL) intrathecal.
| Study group | Role | What they receive |
|---|---|---|
| Group D | Active comparator | Not described Receives: Drug: 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-fr |
| Group F | Active comparator | Not described Receives: Drug: fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate postoperative effect of using intrathecal dexmedetomidine as an adjuvant to heavy bupivacaine in vascular lower limb surgeries on pain intensity.
Pain had been assessed firstly every 1 hour for first 4 hours and subsequently till the patient required analgesia by means of "Visual Analogue Scale", It is lined scale, entails a 10 cm line attached at one end by a marker such as "No pain" and the other end by "Worst pain comprehendible". Patient just made mark on the line to denote the intensity of pain
Measured: 7 hours
evaluate postoperative effect of using intrathecal dexmedetomidine as an adjuvant to heavy bupivacaine in vascular lower limb surgeries on analgesic requirements
First analgesic requirement time was defined as from the time of spinal injection to the time the patient requires analgesia. The rescue analgesic used was Tramadol 50mg IV for visual analogue score of more than 4.
Measured: 7 hours
evaluate postoperative effect of using intrathecal dexmedetomidine as an adjuvant to heavy bupivacaine in vascular lower limb surgeries on shivering. Remove
The incidence and intensity of shivering would be also assessed postoperatively in the recovery room using the method of Tsai and Chu as follows:
0, no shivering
- peripheral vasoconstriction without visible shivering
- muscular activity in only one muscle group
- muscular activity in more than one muscle group
- shivering involving the whole body.
Measured: 7 hours
Secondary outcomes (1)
Complications would be noted post-operative
Complications would be noted post-operative
- Nausea, vomiting, pruritis.
- Incidence of respiratory depression defined as respiratory rate less than 9 /min and SpO2 less than 90% on room air, would be noted, treated with Oxygen (2 L/min) administered via a mask.
- Hypotension (> 20% fall of baseline blood pressure or systolic blood pressure of <100mmHg.) would be treated with bolus dose of 6 mg ephedrine intravenously.
- Bradycardia (pulse rate < 60 bpm) would be treated with 0.3- 0.6 mg atropine intravenously.
Measured: 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start8 Apr 2025
- Primary completion8 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nashwa Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nashwa Ahmed, Port Said University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035223
- Sponsor's protocol ID
- KFSIRB200-594
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhure A, Jagtap N. A comparison of intrathecal dexmedetomidine and fentanyl as an adjuvant to isobaric levobupivacaine for lower limb orthopaedic surgery. Indian Journal of Clinical Anaesthesia 2019;6(1):89-96.
Chandra GP, Krishna SS, Singh P. Comparison of effect of intrathecal dexmedetomidine and clonidine as an adjuvant to hyperbaric bupivacaine in patients undergoing surgery for fracture femur and tibia. Int Surg J. 2017 Dec;4(12):3833-3838.
Reddy NG, Sekar RG, Ahmed CJ, Himabindu M, Mallika CH, Tejaswini PK. Intrathecal nalbuphine versus dexmedetomidine as an adjuvant in spinal anaesthesia for lower limb and lower abdominal surgeries. Journal of Cardiovascular Disease Research 2023;14(2): 825-830.
Ahmed SA, Lotfy HA, Mostafa TAH. The effect of adding dexmedetomidine or dexamethasone to bupivacaine-fentanyl mixture in spinal anesthesia for cesarean section. J Anaesthesiol Clin Pharmacol. 2024 Jan-Mar;40(1):82-89. doi: 10.4103/joacp.joacp_396_22. Epub 2024 Mar 14.
PubMed 38666154Zhang Y, Shan Z, Kuang L, Xu Y, Xiu H, Wen J, Xu K. The effect of different doses of intrathecal dexmedetomidine on spinal anesthesia: a meta-analysis. Int J Clin Exp Med 2016;9(10):18860-18867.
Khare A, Chohala M, Thada B , Mathur V, Garg D , Tanwar N. A study to compare the efficacy of intrathecal dexmedetomidine versus nalbuphine as an adjuvant to 0.5% hyperbaric bupivacaine for postoperative analgesia in lower abdominal surgeries. Ain-Shams Journal of Anesthesiology 2022;14(1):31.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Postoperative Effect Dexmedetomidine or Fentanyl as an Adjuvant to Heavy Bupivacaine in Spinal Anaesthesia in Lower Limb Vascular Surgeries
- ClinicalTrials.gov ID
- NCT07035223
- Acronym / sponsor ID
- KFSIRB200-594
- Conditions
- Postoperative Pain
- Keywords
- fentanyl, bupivacaine, spinal anaesthesia, vascular, dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nashwa AhmedUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 25 Jun 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.
Spinal anaesthesia is an excellent choice of numerous operating procedures. This is due to its effectiveness, rapid onset of action, easy to implement, patient stayed awake, and minimal drug cost.(1) It is also beneficial for patients with chronic airway disorders, reducing the risk of pulmonary aspiration and vomiting in patients with full stomach, as well as its fewer adverse effects, and speedy patient turnover. (2,1) In lower abdominal and lower limb surgeries, spinal anaesthesia is still the primary option. (3) The resultant nerve block is sufficient for patient welfare, while motor block eases the surgeon's work. Moreover, it grants efficient pain relief in the early post-operative period. (2) Yet, postoperative analgesia is a most important dilemma. (4) Thus, additional pain control is essential after spinal anaesthesia effect fades. Consequently, effective analgesia is crucial to accelerate rehabilitation and return to proper functional ability. Post-operative analgesia can be accomplished by numerous approaches specifically systemic opioid and non-opioid, local wound infiltration and peripheral nerve blocks, each approach have its own advantages and drawbacks.
Detailed description
Different adjuvants have been added to local anaesthetics in spinal anaesthesia such as adrenaline, midazolam, clonidine, neostigmine, magnesium, and ketamine to extend the analgesic effect duration and to decrease the prevalence of adverse actions, but no one had been reputable in daily clinical practice. (2,4,5) Administration of opioids intrathecal such as fentanyl, morphine, and buprenorphine, allows decrease dose of the local anesthetic drug, augment analgesic effectiveness, and reduces probable toxicity and cardiovascular adverse consequences of local anesthetics. (5,6) Dexmedetomidine is a novel central alpha2-agonist that was approved by the FDA in 1999.It has sedation, anxiolytic, analgesic and sympatholytic effect that depress cardiovascular reflexes in perioperative interval. (6) Thus, this study will be conducted for assessment of the effectiveness of addition 4 µg Dexmedetomidine to hyperbaric Bupivacaine intrathecally in lower limb surgeries.
Aim This clinical comparative study aiming to evaluate postoperative effect of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb surgeries on pain intensity, analgesic requirement and shivering.
Patients and Methods After approval of medical institutional ethical committee, 40 patients of American Society of Anaesthesiologists (ASA) physical status 1or 2, aged between 20-60 years will be incorporated in this prospective randomized controlled study.
Inclusion Criteria
1- The patient aged range from 20 to 60 years 2- ASA 1 and 2 3- Patient prepared for elective lower limb surgeries. 4- Either sex male or female. Exclusion Criteria
- Patient refusal.
- Patient has absolute contraindication to spinal anaesthesia.
- Patients with ASA 3 or more
- Patients taking ACE inhibitor, adrenergic receptor antagonist and calcium channel blocker.
- Patients with head injury and polytrauma.
An informed written consent will be taken from all the providers. Patients will be divided into the following groups using randomizer software. Group D: patients will receive 3 mL volume of 0.5% hyperbaric bupivacaine and 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-free normal saline, 0.5 ml will be withdrawn) Group F: patients will receive 3 mL volume of 0.5% hyperbaric bupivacaine with 25 µg fentanyl (0.5 mL) intrathecal.
In preoperative room area: clinical history and examination will be evaluated, and then non-invasive BP and heart rate will be measured and recorded as baseline values.
Technique and measurement
- Patients will be moved to operation table, 18G IV access is inserted and secured.
- Preloading begin15minutes before spinal anaesthesia administration with ringer lactated 20ml /kg.
- Intraoperative monitoring involves NIBP, pulse rate, ECG, SPO2
- Patients are divided randomly into two groups by using randomizer software.
- Baseline vital signs will be measured.
- Under strict aseptic technique, after the local infiltration with 2% lignocaine, lumbar puncture is done using 25 G Quincke spinal needle, at L 3 - L 4 space after free flow of csf is verified. Instantly after spinal injection, the patient is placed in a supine position with a cushion supporting shoulders and head. O2 (4-6L/min) is provided throughout face mask.
Post-operative measurement will be collected from instant recovery room to time of the first analgesia dose administrated in the ward Pain will be assessed firstly every 1 hour for first 4 hours and subsequently till the patient required analgesia by means of "Visual Analogue Scale", It is lined scale, entails a 10 cm line attached at one end by a marker such as "No pain" and the other end by "Worst pain comprehendible". Patient just make mark on the line to denote the intensity of pain. (6) First analgesic requirement time is defined as from the time of spinal injection to the time the patient requires analgesia. The rescue analgesic used is Tramadol 50mg IV for visual analogue score of more than 4.
The incidence and intensity of shivering will be also assessed postoperatively in the recovery room using the method of Tsai and Chu as follows: (5) 0, no shivering
- peripheral vasoconstriction without visible shivering
- muscular activity in only one muscle group
- muscular activity in more than one muscle group
- shivering involving the whole body.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | Active comparator | Drug: 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-fr |
| Group F | Active comparator | Drug: fentanyl |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
Key exclusion criteria (2 listed)
- 1- Patient refusal. 2- Patient has absolute contraindication to spinal anaesthesia. 3- Patients with ASA 3 or more 4- Patients taking ACE inhibitor, adrenergic receptor antagonist and calcium channel blocker.
- 5-Patients with head injury and polytrauma.
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 |
|---|---|---|
| 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-frGroup D: patients will receive 3 mL volume of 0.5% hyperbaric bupivacaine and 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-free normal saline, 0.5 ml will be withdrawn) | Drug | Group D |
| fentanylGroup F:patients will receive 3 mL volume of 0.5% hyperbaric bupivacaine with 25 µg fentanyl (0.5 mL) intrathecal. | Drug | Group F |
Primary outcome
evaluate postoperative effect of using intrathecal dexmedetomidine as an adjuvant to heavy bupivacaine in vascular lower limb surgeries on pain intensity.
Time frame: 7 hours
Pain had been assessed firstly every 1 hour for first 4 hours and subsequently till the patient required analgesia by means of "Visual Analogue Scale", It is lined scale, entails a 10 cm line attached at one end by a marker such as "No pain" and the other end by "Worst pain comprehendible". Patient just made mark on the line to denote the intensity of pain
evaluate postoperative effect of using intrathecal dexmedetomidine as an adjuvant to heavy bupivacaine in vascular lower limb surgeries on analgesic requirements
Time frame: 7 hours
First analgesic requirement time was defined as from the time of spinal injection to the time the patient requires analgesia. The rescue analgesic used was Tramadol 50mg IV for visual analogue score of more than 4.
evaluate postoperative effect of using intrathecal dexmedetomidine as an adjuvant to heavy bupivacaine in vascular lower limb surgeries on shivering. Remove
Time frame: 7 hours
The incidence and intensity of shivering would be also assessed postoperatively in the recovery room using the method of Tsai and Chu as follows: 0, no shivering 1. peripheral vasoconstriction without visible shivering 2. muscular activity in only one muscle group 3. muscular activity in more than one muscle group 4. shivering involving the whole body.
1 secondary outcome
Complications would be noted post-operative
Time frame: 7 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Results publicationBhure A, Jagtap N. A comparison of intrathecal dexmedetomidine and fentanyl as an adjuvant to isobaric levobupivacaine for lower limb orthopaedic surgery. Indian Journal of Clinical Anaesthesia 2019;6(1):89-96.
- Results publicationChandra GP, Krishna SS, Singh P. Comparison of effect of intrathecal dexmedetomidine and clonidine as an adjuvant to hyperbaric bupivacaine in patients undergoing surgery for fracture femur and tibia. Int Surg J. 2017 Dec;4(12):3833-3838.
- Results publicationReddy NG, Sekar RG, Ahmed CJ, Himabindu M, Mallika CH, Tejaswini PK. Intrathecal nalbuphine versus dexmedetomidine as an adjuvant in spinal anaesthesia for lower limb and lower abdominal surgeries. Journal of Cardiovascular Disease Research 2023;14(2): 825-830.
- Results publication: PubMed 38666154Ahmed SA, Lotfy HA, Mostafa TAH. The effect of adding dexmedetomidine or dexamethasone to bupivacaine-fentanyl mixture in spinal anesthesia for cesarean section. J Anaesthesiol Clin Pharmacol. 2024 Jan-Mar;40(1):82-89. doi: 10.4103/joacp.joacp_396_22. Epub 2024 Mar 14.
- Results publicationZhang Y, Shan Z, Kuang L, Xu Y, Xiu H, Wen J, Xu K. The effect of different doses of intrathecal dexmedetomidine on spinal anesthesia: a meta-analysis. Int J Clin Exp Med 2016;9(10):18860-18867.
- Results publicationKhare A, Chohala M, Thada B , Mathur V, Garg D , Tanwar N. A study to compare the efficacy of intrathecal dexmedetomidine versus nalbuphine as an adjuvant to 0.5% hyperbaric bupivacaine for postoperative analgesia in lower abdominal surgeries. Ain-Shams Journal of Anesthesiology 2022;14(1):31.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-fr and fentanyl in people with Postoperative Pain, run by Nashwa Ahmed at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 25 Jun 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate postoperative effect of using intrathecal dexmedetomidine as an adjuvant to heavy bupivacaine in vascular lower limb surgeries on pain intensity. (time frame: 7 hours). The study lists 3 primary outcomes in all. 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 NCT07035223, which also lists 6 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 25 Jun 2025.