Comparison Between Intrathecal and Intravenous Dexmedetomidine

Postoperative Analgesia Clinical Trial

Official title:

Comparison Study Between Intrathecal and Intravenous Dexmedetomidine in Lower Limb Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04374318
• Other study ID #: Dex IT IV
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: May 2020
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 30, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Analgesia

Intervention

Drug:
• Dexmedetomidine
INTRATHECAL AND INTRAVENOUS

Locations

Country	Name	City	State
Egypt	Suez Canal University	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First request to analgesia	The first time the patient is asking for analgesia to control his pain	Postoperative up to 24 hours
Secondary	Total postoperative analgesia consumption	Total consumption of analgesia to control pain	Postoperative up to 24 hours
Secondary	visual analogue scale	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	Every two hours for 24 hours postoperative