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Completed

NCT Number: NCT04374318

Comparison Between Intrathecal and Intravenous Dexmedetomidine

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez Canal University

Ismailia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

INTRATHECAL AND INTRAVENOUS

Other names: precidex

Primary outcomes

  1. 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

  1. Total postoperative analgesia consumption

    Time frame: Postoperative up to 24 hours

    Total consumption of analgesia to control pain

  2. visual analogue scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

Comparison Study Between Intrathecal and Intravenous Dexmedetomidine in Lower Limb Surgeries

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 5, 2020
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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