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

Effect of Different Doses Of Intrathecal Dexmedetomidine In Combination With Bupivacaine On Spinal Anesthesia And Its Postoperative Analgesic Effects In Patients Undergoing Infra-Umbilical Surgeries.

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.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia Evaluation; Analgesic; Intrathecal Anesthesia
• Intervention / Treatment: Drug: dexmedetomidine 4μg; Drug: dexmedetomidine 8 μg; Drug: dexmedetomidine 10 μg

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group (I):dexmedetomidine 4μg; Group (I): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 4μg)	Drug: dexmedetomidine 4μg; patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 4μg)
Experimental: Group (II): dexmedetomidine 8 μg; Group (II): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 8 μg)	Drug: dexmedetomidine 8 μg; patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 8 μg)
Experimental: Group (III): dexmedetomidine 10 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 10 μg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Intraoperative during 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	24 hours post-spinal injection

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Marwa Elakraa, Resident, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: June 26, 2025
• First Submitted That Met QC Criteria: June 26, 2025
• First Posted (Actual): July 4, 2025

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Bupivacaine; Spinal Anesthesia; Postoperative Analgesic; Infra-Umbilical Surgeries
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine
• Other Study ID Numbers: 36264MS266/7/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No