Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy

NCT ID: NCT04607525

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-21
• Study Completion Date: 2021-01-26

Brief Summary

There is no clear consensus among neuroanesthesiologists regarding which anesthetic regimen is optimal for craniotomy. Propofol and short-acting opioids (such as remifentanil, fentanyl, or sufentanil) are commonly used. However, use of opioids is associated with increased risk of respiratory depression and postoperative nausea and vomiting. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist that has been considered as a useful and safe adjunct to anesthesia for various surgical procedures

Detailed Description

The investigators designed this randomized, double-blind study to evaluate the effectiveness of administration of Dexmedetomidine infusion at a dose of 0.5 µg/kg/h without loading dose during elective supratentorial craniotomy under GA. The investigators will compare intraoperative hemodynamics in both groups, intraoperative analgesic consumption, intraoperative blood loss, postoperative sedation scores, intraoperative need for rescue hypotensive agents, and finally the satisfaction of surgeons.

To our knowledge, the present study is the first to evaluate the effect of Dexmedetomidine infusion without loading dose in elective supratentorial craniotomy

Conditions

Hemodynamic Instability; Supratentorial Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group D

Group D: Patients received 0.5 µg/kg/h of Dexmedetomidine. Dexmedetomidine dosage was diluted in 50 ml syringe of normal saline

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

On the scheduled time of operation, the head nurse opened each envelope just before surgery, prepared the infusion solution and handled it to the anesthesiologist who was blinded to the solution. He was then determined for collecting perioperative data.

Group D: Patients received 0.5 µg/kg/h of Dexmedetomidine. Dexmedetomidine dosage was diluted in 50 ml syringe of normal saline Group C: Patients received equal volume and rate of normal saline as Group D.

This dosing regimen was in accordance with existing guidelines [5] [6] [7].

Group C

Patients received equal volume and rate of normal saline as Group D.

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

On the scheduled time of operation, the head nurse opened each envelope just before surgery, prepared the infusion solution and handled it to the anesthesiologist who was blinded to the solution. He was then determined for collecting perioperative data.

Group C: Patients received equal volume and rate of normal saline as Group D.

Interventions

Dexmedetomidine

On the scheduled time of operation, the head nurse opened each envelope just before surgery, prepared the infusion solution and handled it to the anesthesiologist who was blinded to the solution. He was then determined for collecting perioperative data.

Group D: Patients received 0.5 µg/kg/h of Dexmedetomidine. Dexmedetomidine dosage was diluted in 50 ml syringe of normal saline Group C: Patients received equal volume and rate of normal saline as Group D.

This dosing regimen was in accordance with existing guidelines [5] [6] [7].

Intervention Type: DRUG

normal saline

On the scheduled time of operation, the head nurse opened each envelope just before surgery, prepared the infusion solution and handled it to the anesthesiologist who was blinded to the solution. He was then determined for collecting perioperative data.

Group C: Patients received equal volume and rate of normal saline as Group D.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• American society of anesthesiologists- Physical status (ASA-PS) I and II patients,
• aged 18 to 65 years
• 70-80 kg
• both sexes
• undergoing elective supratentorial craniotomy for tumor resection

Exclusion Criteria

• Patients under 18 years of age
• pregnancy,
• emergency surgery
• patients with a Glasgow Coma Score (GCS) less than 15.
• Those who had respiratory or cardiac dysfunction, renal insufficiency, liver impairment, or bleeding disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Raham Hasan Mostafa, MD

Assistant Professor of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

R 115 / 2020

Identifier Type: -

Identifier Source: org_study_id