NCT07051512

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	dexmedetomidine 4μg	patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 4μg)
DRUG	dexmedetomidine 8 μg	patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 8 μg)
DRUG	dexmedetomidine 10 μg	patients received (0.5% hyperbaric bupivacaine 12.5 mg + dexmedetomidine 10 μg).

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2025-07-04
• Last updated: 2025-07-04

Locations

1 site across 1 country: Egypt