A Phase 1 interventional study of dexmedetomidine 4μg and dexmedetomidine 8 μg in Spinal Anesthesia Evaluation, Analgesic and Intrathecal Anesthesia, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-07-04.
Sponsored by Tanta University · Phase 1, Interventional, and Prevention
This study is designed to assess the efficacy of different doses of dexmedetomidine in combination with intrathecal hyperbaric bupivacaine on spinal anesthesia and its postoperative analgesic characteristics on patients undergoing infra-umbilical procedures.
Primary outcome:
To ascertain a safe intrathecal dexmedetomidine dose for patients undergoing elective lower abdominal and lower limb surgeries
Secondary outcomes:
Assessment of level of sedation. Assessment of hemodynamic parameters (Blood Pressure -Heart Rate). Assessment of level of sensory \& motor block. Assessment of pain.
Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. A pain free and stress free postoperative period helps in early mobilization and recovery of surgical patients, thereby reducing morbidity. Intraoperative and postoperative pain relief is a fundamental component of anesthesia. Accordingly, anesthesiologists constantly strive to offer the best possible anesthetic technique with emphasis on minimum adverse effects and satisfactory perioperative analgesia. Spinal anesthesia is a preferred technique to administer anesthesia for infraumbilical operations. However, postoperative pain control is a matter of concern with spinal anesthesia using only local anesthetics, as the analgesic effect lasts for a relatively short duration. Thus, early analgesic intervention is needed in the postoperative period.
Various adjuvants, such as opioids, epinephrine, neostigmine, magnesium, midazolam, ketamine, clonidine, have been used with intrathecal local anesthetics in attempts to prolong analgesia and reduce the incidence of adverse events. In recent years, α2-adrenergic receptor agonists have gained popularity as an important adjunct in anesthetic practice, whether it be general or regional anesthesia.
Dexmedetomidine is selective alpha-2 agonist with favorable analgesic, sedative, anxiolytic, and sympatholytic features. Researchers have used dexmedetomidine intrathecally in varying doses with varying results. Despite extensive research, no consensus on optimal dose of intrathecal dexmedetomidine exists, since with higher doses there is better intraoperative and post-operative analgesia, but there is an increased likelihood of hemodynamic disturbances.
This prompted us to conduct this research to study varying doses of intrathecal dexmedetomidine to compare the prolongation of sensory and motor block duration with dosage ranging from as low as 4 μg to as high as 10 μg as adjuvant along with 0.5% hyperbaric bupivacaine. Anticipated benefits/outcomes included prolongation of sensory and motor block with reduced/ delayed need of rescue analgesics in the post-operative period and with reduced intraoperative and post-operative side effects.
This study is designed to assess the efficacy of different doses of dexmedetomidine in combination with intrathecal hyperbaric bupivacaine on spinal anesthesia and its postoperative analgesic characteristics on patients undergoing infra-umbilical procedures.
Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
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Exclusion Criteria:
Group (I): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 4μg)
Drug: dexmedetomidine 4μg
Group (II): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 8 μg)
Drug: dexmedetomidine 8 μg
Group (III): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 10 μg
Drug: dexmedetomidine 10 μg
patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 4μg)
patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 8 μg)
patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 10 μg).
intrathecal dexmedetomidine dose
To ascertain a safe intrathecal dexmedetomidine dose for patients undergoing elective lower abdominal and lower limb surgeries.3. The sensory block level will be assessed at 5 min , 20 min after administration of spinal anesthesia and every 15 min postoperative until two segment sensory regression.
Time frame: 2 hours
A safe intrathecal dexmedetomidine dose for patients
To ascertain a safe intrathecal dexmedetomidine dose for patients undergoing elective lower abdominal and lower limb surgeries
Time frame: Intraoperative during 2 hours
pain by Visual analogue scale
The pain onset time in the postoperative period will be assessed using Visual analogue scale hourly for the first 4hours, then every 4 hours for the next 8 hours, and at 24 hours postoperatively.
Time frame: 24 hours postoperatively.
intraoperative sedation level using the Ramsay sedation scale
The intraoperative sedation level of the patients will be assessed using the Ramsay sedation scale. The patient will be considered to be sedated if the Ramsay sedation scale score was ≥2 and will be assessed hourly till 4 hours after surgery and then at 8 hours, 12 hours and 24 hours post-spinal injection.
Time frame: 24 hours post-spinal injection
Plan to share: Undecided
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Tanta University