Comparison Between Intrathecal and Intravenous Dexmedetomidine

Not Applicable

Completed

• Conditions: Postoperative Analgesia
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT04374318
• Lead Sponsor: Suez Canal University

Brief Summary

A prospective, randomized, comparative controlled clinical trial, aiming to compare the use of intrathecal dexmedetomidine by intravenous dexmedetomidine in concern of the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.

Detailed Description

Seventy patients undergoing lower limb surgeries were included in this study. Using a random number sequence, patients were enrolled in one of two groups: Group T receiving 5 µg of dexmedetomidine (Precedex® 100 µg/mL, Hospira, Inc., IL, U.S.A.) combined with 12.5 mg of 0.5% hyperbaric bupivacaine (Marcaine® Spinal Heavy; Astra, Sodertalje, Sweden) and Group V receiving the same bupivacaine DOSE AND 0.75 microgram/kilogram of body weight dexmedetomidine intravenously. Dexmedetomidine 100 µg/mL was mixed with preservative-free normal saline to 10 µg/mL. The 0.5 mL of dilute dexmedetomidine was added to the bupivacaine in group T. An independent investigator prepared the drug solutions and provided the coded drug to the anaesthetic administrator before the start of the anaesthesia. The anaesthetic administrator, patients, outcome assessors, and data analysts were blinded to the allocation. Spinal Anesthesia Patients were hydrated with 500 mL of 0.9% sodium chloride solution before anaesthesia. The spinal puncture was performed at L3-4 or L4-5 with a midline approach using a 25 G Quincke needle in the lateral decubitus position. After confirmation of free flow and clear cerebrospinal fluid, the drug was administered and the patients were then placed in the supine neutral position.

Assessment: The primary end-point of this study was the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-10-30
• Study Completion: 2020-03-30
• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-04-30
• Status Verified: 2020-05
• Study First Posted: 2020-05-05
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• ASA I-II patients
• age 18-65 years
• scheduled for lower limb surgery
• spinal anaesthesia

Exclusion Criteria

• patients with coagulopathy
• infection at the site of lumbar puncture
• beta-blockers or calcium channel blockers usage
• hypersensitivity to Bupivacaine or Dexmedetomidine
• any other contra-indications for spinal anaesthesia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IT intrathecal	Dexmedetomidine	administration of intrathecal dexmedetomidine in addition to bupivacaine for lower limb surgeries
IV intravenous	Dexmedetomidine	administration of intravenous dexmedetomidine in addition to spinal anaesthesia for lower limb surgeries

Primary Outcome Measures

Name	Time	Method
First request to analgesia	Postoperative up to 24 hours	The first time the patient is asking for analgesia to control his pain

Secondary Outcome Measures

Name	Time	Method
Total postoperative analgesia consumption	Postoperative up to 24 hours	Total consumption of analgesia to control pain
visual analogue scale	Every two hours for 24 hours postoperative	The score subjectively measures the severity of pain and it is ranging from 0 when there is no pain to 10 when it is the worse pain imaginable

Trial Locations

Locations (1)

Suez Canal University; 🇪🇬 Ismailia, Egypt