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Clinical Trials/NCT04374318
NCT04374318
Completed
Not Applicable

Comparison Study Between Intrathecal and Intravenous Dexmedetomidine in Lower Limb Surgeries

Suez Canal University1 site in 1 country70 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Dexmedetomidine
Conditions
Postoperative Analgesia
Sponsor
Suez Canal University
Enrollment
70
Locations
1
Primary Endpoint
First request to analgesia
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
March 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abdelrhman Alshawadfy

Lecturer of anesthesia and intensive care

Suez Canal University

Eligibility Criteria

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.

Arms & Interventions

IT intrathecal

administration of intrathecal dexmedetomidine in addition to bupivacaine for lower limb surgeries

Intervention: Dexmedetomidine

IV intravenous

administration of intravenous dexmedetomidine in addition to spinal anaesthesia for lower limb surgeries

Intervention: Dexmedetomidine

Outcomes

Primary Outcomes

First request to analgesia

Time Frame: Postoperative up to 24 hours

The first time the patient is asking for analgesia to control his pain

Secondary Outcomes

  • Total postoperative analgesia consumption(Postoperative up to 24 hours)
  • visual analogue scale(Every two hours for 24 hours postoperative)

Study Sites (1)

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