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

NCT ID: NCT07051512

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-06-30

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.

Conditions

Spinal Anesthesia Evaluation; Analgesic; Intrathecal Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group (I):dexmedetomidine 4μg

Group (I): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 4μg)

Group Type: EXPERIMENTAL

dexmedetomidine 4μg

Intervention Type: DRUG

patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 4μg)

Group (II): dexmedetomidine 8 μg

Group (II): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 8 μg)

Group Type: EXPERIMENTAL

dexmedetomidine 8 μg

Intervention Type: DRUG

patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 8 μg)

Group (III): dexmedetomidine 10 μg

Group (III): in this group patients will receive (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 10 μg

Group Type: EXPERIMENTAL

dexmedetomidine 10 μg

Intervention Type: DRUG

patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 10 μg).

Interventions

dexmedetomidine 4μg

patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 4μg)

Intervention Type: DRUG

dexmedetomidine 8 μg

patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 8 μg)

Intervention Type: DRUG

dexmedetomidine 10 μg

patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 10 μg).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Gamal Abd-Elnaby Elakraa

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa Elakraa, Resident

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Tanta University

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

36264MS266/7/23

Identifier Type: -

Identifier Source: org_study_id