Spinal Anesthesia DurationPhase 4NCT07078201
Comparative Analysis of Intraoperative Effect Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Spinal Anaesthesia in Lower Limb Orthopedic Surgeries to Evaluate the Hemodynamic Stability and Onset and Duration of Motor Block of Using Intrathecal Dexmedetomidine and Fentanyl
A Phase 4 study testing Dexmedetomidine and fentanyl in people with Spinal Anesthesia Duration, run by Nashwa Ahmed at 1 site in Egypt.
Trial summary
Spinal anesthesia is the most widely employed procedure for lower limb orthopedic operations, as it is very cost-effective and simple to apply. These advantages could be restricted because presently existing local anesthetic drugs had relatively short length of action. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Spinal Anesthesia Duration
- What is being tested?
- Dexmedetomidine and fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 25 Dec 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 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 orthopaedic surgeries.
- Height 150-180 cm.
- Weight 50-70 kg. 6- Either sex male or female.
Who cannot join
- 1- Patient refusal. 2- Patient had absolute contraindication to spinal anaesthesia. 3-Patients with neurological disorders, pregnancy, local infection at the site of injection.
- 4- Patients suffering from dysrhythmia or heart block. 5- Patients with ASA 3 or more.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Port said university
Port Said, 42111
nashwa gomaa ahmed, MD, 00201005289328, dr_nashwa_2008@yahoo.com
About this study
Official title: Comparative Analysis of Intraoperative Effect Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Spinal Anaesthesia in Lower Limb Orthopedic Surgeries.
Spinal anesthesia is the most widely employed procedure for lower limb orthopedic operations, as it is very cost-effective and simple to apply. These advantages could be restricted because presently existing local anesthetic drugs had relatively short length of action. (1) Spinal anesthesia with 0.5% heavy bupivacaine (hyperbaric) is a common technique, still there was burden of its short duration of action. To overcome this issue, there was a continuous search for an ideal adjuvant.(2) Adjuvants were mostly added to local anesthetic drugs to increase their effectiveness, speedy onset, increase the period of the block, and reduce the local anesthetics dosage, thus reduction their adverse effects.(3) Such adjuvants had been beneficial in extension of analgesia along with initiation of movement though their related side effects.(4)
Read the detailed description
Administration of opioids intrathecal such as fentanyl, morphine, and buprenorphine, allowed decreasing dose of the local anesthetic drug, augment analgesic effectiveness, and reduce probable toxicity and cardiovascular adverse consequences of local anesthetics. (5, 2) Nevertheless, adverse effects such as possibly disastrous delayed respiratory depression, urinary retention, nausea, pruritus, vomiting, and constipation had provoked further study to investigate non opioid analgesic drugs with less troublesome drawbacks. (6,2,7,8) Dexmedetomidine is a novel central alpha2-agonist that was approved by the FDA in 1999. It had sedation, anxiolytic, analgesic, and sympatholytic effect that depress cardiovascular reflexes in perioperative interval. (2) Thus, this study had been conducted for assessment of the effectiveness of addition 4 µg Dexmedetomidine to hyperbaric Bupivacaine intrathecally in lower limb orthopaedic surgeries.
Aim This clinical comparative study aimed to evaluate the hemodynamic stability and onset and duration of motor block of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopaedic surgeries.
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 had been incorporated in this prospective randomized controlled study.
Inclusion Criteria
- The patient aged range from 20 to 60 years 2. ASA 1 and 2 3. Patient prepared for elective lower limb orthopaedic surgeries. 4. Height 150-180 cm. 5. Weight 50-70 kg. 6- Either sex male or female. Exclusion Criteria
- Patient refusal.
- Patient had absolute contraindication to spinal anaesthesia.
- Patients with neurological disorders, pregnancy, local infection at the site of injection.
- Patients suffering from dysrhythmia or heart block.
- Patients with ASA 3 or more. An informed written consent had been taken from all the contributors. Patients had been divided into the following groups using randomizer software. Group D: patients received 3 mL volume of 0.5% hyperbaric bupivacaine and 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL diluted in 12.5 ml preservative-free normal saline, 0.5 ml had been withdrawn).
Group F: patients received 3 mL volume of 0.5% hyperbaric bupivacaine with 25 µg fentanyl (0.5 mL) intrathecal.
In preoperative room area: clinical history and examination had been evaluated, and then non-invasive blood pressure and heart rate had been measured and recorded as baseline values.
Anesthetic technique
- Patients would be moved to operation table, 18G IV access was inserted and secured.
- Preloading began15minutes before spinal anaesthesia administration with ringer lactated 20ml /kg.
- Intraoperative monitoring involved NIBP, pulse rate, ECG, SPO2.
- Patients were divided randomly into two groups by using randomizer software.
- Baseline vital signs had been measured. Under strict aseptic technique, after the local infiltration with 2% lignocaine, lumbar puncture was done using 25 G Quincke spinal needle, at L 3 - L 4 space after free flow of csf was verified. Instantly after spinal injection, the patient was placed in a supine position with a cushion supporting shoulders and head. O2 (4-6L/min) had been provided throughout face mask.
The following parameters had been measured: Intraoperatively non-invasive mean blood pressure and heart rate had been documented, every 15 min for first 30minutes then every 30 min till the end of the surgery. onset time of bromage 3 motor block had been recorded (Onset of the motor block; period between the ending of intrathecal drug injection and entire motor paralysis) Duration of motor block had been evaluated by the time taken to return from complete Bromage motor block (bromage 3) to scale 0.
Motor block was evaluated with Modified Bromage scale (6) Bromage 0: The patient could move the hip, knee, and ankle. Bromage 1: The patient could move the hip but had ability to move the knee and ankle.
Bromage 2: The patient could move the hip and knee but had ability to move the ankle.
Bromage 3: The patient could not move the hip, knee, and ankle.
Complications would be noted Intraoperative:
nausea, vomiting, pruritis. Hypotension (> 20% fall of baseline blood pressure or systolic blood pressure of <100mmHg.) had been treated with bolus dose of 6 mg ephedrine IV Bradycardia (pulse rate < 60 bpm), had been treated with 0.3- 0.6 mg atropine IV Incidence of respiratory depression defined as respiratory rate less than 9 /min and SpO2 less than 90% on room air, would be noted, it had been treated with Oxygen (2 L/min), administered via a mask.
- Conditions
- Spinal Anesthesia Duration
- Being tested
- Dexmedetomidine, fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
patients received 3 mL volume of 0.5% hyperbaric bupivacaine and 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL diluted in 12.5 ml preservative-free normal saline, 0.5 ml had been withdrawn).
fentanylDrug
patients received 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: Dexmedetomidine |
| 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.
to evaluate duration of motor block of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.
Duration of motor block had been evaluated by the time taken to return from complete Bromage motor block (bromage 3) to scale 0.
Motor block was evaluated with Modified Bromage scale (6) Bromage 0: The patient could move the hip, knee, and ankle. Bromage 1: The patient could move the hip but had ability to move the knee and ankle.
Bromage 2: The patient could move the hip and knee but had ability to move the ankle.
Bromage 3: The patient could not move the hip, knee, and ankle.
Measured: 7 hour
evaluate onset of motor block of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.
onset time of bromage 3 motor block had been recorded (Onset of the motor block; period between the ending of intrathecal drug injection and entire motor paralysis)
Measured: 10 minutes
to evaluate non invasive mean blood pressure using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.
Intraoperatively non-invasive mean blood pressure had been documented, every 15 min for first 30minutes then every 30 min till the end of the surgery.
Measured: 90 minutes
to evaluate the heart rate using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.
Intraoperatively heart rate had been documented, every 15 min for first 30minutes then every 30 min till the end of the surgery.
Measured: 90 minutes
Secondary outcomes (1)
Complications would be noted Intraoperative
nausea, vomiting, pruritis. Hypotension (> 20% fall of baseline blood pressure or systolic blood pressure of <100mmHg.) had been treated with bolus dose of 6 mg ephedrine IV Bradycardia (pulse rate < 60 bpm), had been treated with 0.3- 0.6 mg atropine IV Incidence of respiratory depression defined as respiratory rate less than 9 /min and SpO2 less than 90% on room air, would be noted, it had been treated with Oxygen (2 L/min), administered via a mask.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jul 2025
- Primary completion15 Jul 2025
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Spinal Anesthesia DurationStudies 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 (estimated)
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
- NCT07078201
- Sponsor's protocol ID
- IRB00012098- Serial0307331
- Status last verified
- Dec 2025
- First submitted
- 28 Jun 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gupta R, Verma R, Bogra J, Kohli M, Raman R, Kushwaha JK. A Comparative study of intrathecal dexmedetomidine and fentanyl as adjuvants to Bupivacaine. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):339-43. doi: 10.4103/0970-9185.83678.
PubMed 21897504Rajasekaran S, Murugaih S, Anandan A, Ramalingam A. A comparative study of intrathecal clonidine VS dexmedetomidine in caesarean patients. Indian Journal of Clinical Anaesthesia 2018;5(1):68-74.
Sharma E, Gupta B, Verma RK, Devra V. Block characteristics of different doses of intrathecal dexmedetomidine when combined with low dose heavy bupivacaine for gynecological surgeries: a double blind, randomised comparative study. Sch. J. App. Med. Sci., 2017; 5(6D):2286-2294.
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 38666154Gupta A, Gupta KL, Yadav M. To evaluate the effect of addition of dexmedetomidine to hyperbaric bupivacaine intrathecally in infraumblical surgeries. International Journal of Contemporary Medical Research 2016;3(7):2136-2138.
Kumar S, Choudhury B, Varikasuvu SR, Singh H, Kumar S, Lahon J, Saikia D. A Systematic Review and Meta-analysis of Efficacy and Safety of Dexmedetomidine Combined With Intrathecal Bupivacaine Compared to Placebo. Cureus. 2022 Dec 12;14(12):e32425. doi: 10.7759/cureus.32425. eCollection 2022 Dec.
PubMed 36644042Reddy 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): 825-883.
Zhang 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Intraoperative Effect Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Spinal Anaesthesia in Lower Limb Orthopedic Surgeries.
- ClinicalTrials.gov ID
- NCT07078201
- Acronym / sponsor ID
- IRB00012098- Serial0307331
- Conditions
- Spinal Anesthesia Duration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nashwa AhmedUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 22 Jul 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 anesthesia is the most widely employed procedure for lower limb orthopedic operations, as it is very cost-effective and simple to apply. These advantages could be restricted because presently existing local anesthetic drugs had relatively short length of action. (1) Spinal anesthesia with 0.5% heavy bupivacaine (hyperbaric) is a common technique, still there was burden of its short duration of action. To overcome this issue, there was a continuous search for an ideal adjuvant.(2) Adjuvants were mostly added to local anesthetic drugs to increase their effectiveness, speedy onset, increase the period of the block, and reduce the local anesthetics dosage, thus reduction their adverse effects.(3) Such adjuvants had been beneficial in extension of analgesia along with initiation of movement though their related side effects.(4)
Detailed description
Administration of opioids intrathecal such as fentanyl, morphine, and buprenorphine, allowed decreasing dose of the local anesthetic drug, augment analgesic effectiveness, and reduce probable toxicity and cardiovascular adverse consequences of local anesthetics. (5, 2) Nevertheless, adverse effects such as possibly disastrous delayed respiratory depression, urinary retention, nausea, pruritus, vomiting, and constipation had provoked further study to investigate non opioid analgesic drugs with less troublesome drawbacks. (6,2,7,8) Dexmedetomidine is a novel central alpha2-agonist that was approved by the FDA in 1999. It had sedation, anxiolytic, analgesic, and sympatholytic effect that depress cardiovascular reflexes in perioperative interval. (2) Thus, this study had been conducted for assessment of the effectiveness of addition 4 µg Dexmedetomidine to hyperbaric Bupivacaine intrathecally in lower limb orthopaedic surgeries.
Aim This clinical comparative study aimed to evaluate the hemodynamic stability and onset and duration of motor block of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopaedic surgeries.
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 had been incorporated in this prospective randomized controlled study.
Inclusion Criteria
- The patient aged range from 20 to 60 years 2. ASA 1 and 2 3. Patient prepared for elective lower limb orthopaedic surgeries. 4. Height 150-180 cm. 5. Weight 50-70 kg. 6- Either sex male or female. Exclusion Criteria
- Patient refusal.
- Patient had absolute contraindication to spinal anaesthesia.
- Patients with neurological disorders, pregnancy, local infection at the site of injection.
- Patients suffering from dysrhythmia or heart block.
- Patients with ASA 3 or more. An informed written consent had been taken from all the contributors. Patients had been divided into the following groups using randomizer software. Group D: patients received 3 mL volume of 0.5% hyperbaric bupivacaine and 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL diluted in 12.5 ml preservative-free normal saline, 0.5 ml had been withdrawn).
Group F: patients received 3 mL volume of 0.5% hyperbaric bupivacaine with 25 µg fentanyl (0.5 mL) intrathecal.
In preoperative room area: clinical history and examination had been evaluated, and then non-invasive blood pressure and heart rate had been measured and recorded as baseline values.
Anesthetic technique
- Patients would be moved to operation table, 18G IV access was inserted and secured.
- Preloading began15minutes before spinal anaesthesia administration with ringer lactated 20ml /kg.
- Intraoperative monitoring involved NIBP, pulse rate, ECG, SPO2.
- Patients were divided randomly into two groups by using randomizer software.
- Baseline vital signs had been measured. Under strict aseptic technique, after the local infiltration with 2% lignocaine, lumbar puncture was done using 25 G Quincke spinal needle, at L 3 - L 4 space after free flow of csf was verified. Instantly after spinal injection, the patient was placed in a supine position with a cushion supporting shoulders and head. O2 (4-6L/min) had been provided throughout face mask.
The following parameters had been measured: Intraoperatively non-invasive mean blood pressure and heart rate had been documented, every 15 min for first 30minutes then every 30 min till the end of the surgery. onset time of bromage 3 motor block had been recorded (Onset of the motor block; period between the ending of intrathecal drug injection and entire motor paralysis) Duration of motor block had been evaluated by the time taken to return from complete Bromage motor block (bromage 3) to scale 0.
Motor block was evaluated with Modified Bromage scale (6) Bromage 0: The patient could move the hip, knee, and ankle. Bromage 1: The patient could move the hip but had ability to move the knee and ankle.
Bromage 2: The patient could move the hip and knee but had ability to move the ankle.
Bromage 3: The patient could not move the hip, knee, and ankle.
Complications would be noted Intraoperative:
nausea, vomiting, pruritis. Hypotension (> 20% fall of baseline blood pressure or systolic blood pressure of <100mmHg.) had been treated with bolus dose of 6 mg ephedrine IV Bradycardia (pulse rate < 60 bpm), had been treated with 0.3- 0.6 mg atropine IV Incidence of respiratory depression defined as respiratory rate less than 9 /min and SpO2 less than 90% on room air, would be noted, it had been treated with Oxygen (2 L/min), administered via a mask.
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: Dexmedetomidine |
| 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 (5 listed)
- The patient aged range from 20 to 60 years
- ASA 1 and 2
- Patient prepared for elective lower limb orthopaedic surgeries.
- Height 150-180 cm.
- Weight 50-70 kg. 6- Either sex male or female.
Key exclusion criteria (2 listed)
- 1- Patient refusal. 2- Patient had absolute contraindication to spinal anaesthesia. 3-Patients with neurological disorders, pregnancy, local infection at the site of injection.
- 4- Patients suffering from dysrhythmia or heart block. 5- Patients with ASA 3 or more.
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 |
|---|---|---|
| Dexmedetomidinepatients received 3 mL volume of 0.5% hyperbaric bupivacaine and 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL diluted in 12.5 ml preservative-free normal saline, 0.5 ml had been withdrawn). | Drug | Group D |
| fentanylpatients received 3 mL volume of 0.5% hyperbaric bupivacaine with 25 µg fentanyl (0.5 mL) intrathecal. | Drug | Group F |
Primary outcome
to evaluate duration of motor block of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.
Time frame: 7 hour
Duration of motor block had been evaluated by the time taken to return from complete Bromage motor block (bromage 3) to scale 0. Motor block was evaluated with Modified Bromage scale (6) Bromage 0: The patient could move the hip, knee, and ankle. Bromage 1: The patient could move the hip but had ability to move the knee and ankle. Bromage 2: The patient could move the hip and knee but had ability to move the ankle. Bromage 3: The patient could not move the hip, knee, and ankle.
evaluate onset of motor block of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.
Time frame: 10 minutes
onset time of bromage 3 motor block had been recorded (Onset of the motor block; period between the ending of intrathecal drug injection and entire motor paralysis)
to evaluate non invasive mean blood pressure using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.
Time frame: 90 minutes
Intraoperatively non-invasive mean blood pressure had been documented, every 15 min for first 30minutes then every 30 min till the end of the surgery.
to evaluate the heart rate using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.
Time frame: 90 minutes
Intraoperatively heart rate had been documented, every 15 min for first 30minutes then every 30 min till the end of the surgery.
1 secondary outcome
Complications would be noted Intraoperative
Time frame: 90 minutes
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 30 Dec 2025.
- Results publication: PubMed 21897504Gupta R, Verma R, Bogra J, Kohli M, Raman R, Kushwaha JK. A Comparative study of intrathecal dexmedetomidine and fentanyl as adjuvants to Bupivacaine. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):339-43. doi: 10.4103/0970-9185.83678.
- Results publicationRajasekaran S, Murugaih S, Anandan A, Ramalingam A. A comparative study of intrathecal clonidine VS dexmedetomidine in caesarean patients. Indian Journal of Clinical Anaesthesia 2018;5(1):68-74.
- Results publicationSharma E, Gupta B, Verma RK, Devra V. Block characteristics of different doses of intrathecal dexmedetomidine when combined with low dose heavy bupivacaine for gynecological surgeries: a double blind, randomised comparative study. Sch. J. App. Med. Sci., 2017; 5(6D):2286-2294.
- 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 publicationGupta A, Gupta KL, Yadav M. To evaluate the effect of addition of dexmedetomidine to hyperbaric bupivacaine intrathecally in infraumblical surgeries. International Journal of Contemporary Medical Research 2016;3(7):2136-2138.
- Results publication: PubMed 36644042Kumar S, Choudhury B, Varikasuvu SR, Singh H, Kumar S, Lahon J, Saikia D. A Systematic Review and Meta-analysis of Efficacy and Safety of Dexmedetomidine Combined With Intrathecal Bupivacaine Compared to Placebo. Cureus. 2022 Dec 12;14(12):e32425. doi: 10.7759/cureus.32425. eCollection 2022 Dec.
- 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): 825-883.
- 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.
- 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.
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 Dexmedetomidine and fentanyl in people with Spinal Anesthesia Duration, 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 5 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: looking for participants now, as of the sponsor's last update on 30 Dec 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?
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 Nashwa gomaa Ahmed, MD (00201005289328, dr_nashwa_2008@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate duration of motor block of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries. (time frame: 7 hour). The study lists 4 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 NCT07078201, which also lists 8 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 30 Dec 2025.