Effect of Different Doses Of Intrathecal Dexmedetomidine In Combination With Bupivacaine On Spinal Anesthesia

Not Applicable

Completed

• Conditions: Spinal Anesthesia Evaluation; Analgesic; Intrathecal Anesthesia
• Interventions: Drug: dexmedetomidine 4μg; Drug: dexmedetomidine 10 μg; Drug: dexmedetomidine 8 μg

• Registration Number: NCT07051512
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2025-06
• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Age 18-60 years of either sex.
• American Society of Anesthesiologists physical status I and II.
• undergoing elective lower abdominal and lower limb surgeries under planned subarachnoid block.

Exclusion Criteria

• patient refusal
• contraindication to subarachnoid block (hypersensitivity to the drugs - infection at the site of injection)
• significant comorbid conditions like congestive heart failure, coagulopathy, heart block
• pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (I):dexmedetomidine 4μg	dexmedetomidine 4μg	Group (I): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 4μg)
Group (III): dexmedetomidine 10 μg	dexmedetomidine 10 μg	Group (III): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 10 μg
Group (II): dexmedetomidine 8 μg	dexmedetomidine 8 μg	Group (II): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 8 μg)

Primary Outcome Measures

Name	Time	Method
intrathecal dexmedetomidine dose	2 hours	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.
A safe intrathecal dexmedetomidine dose for patients	Intraoperative during 2 hours	To ascertain a safe intrathecal dexmedetomidine dose for patients undergoing elective lower abdominal and lower limb surgeries

Secondary Outcome Measures

Name	Time	Method
pain by Visual analogue scale	24 hours postoperatively.	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.
intraoperative sedation level using the Ramsay sedation scale	24 hours post-spinal injection	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Gharbia, Egypt