Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy

Phase 4

Completed

• Conditions: Hemodynamic Instability; Supratentorial Neoplasms
• Interventions: Drug: Dexmedetomidine; Drug: normal saline

• Registration Number: NCT04607525
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-10-29
• Study Start: 2020-11-21
• Primary Completion: 2021-01-20
• Study Completion: 2021-01-26
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-26
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mean areterial blood pressure	4 to 8 hours	incidence of intraoperative hemodynamic stability
Heart rate	4 to 8 hours	incidence of intraoperative hemodynamic stability
Number of Participants needed rescue agents	4 to 8 hours

Secondary Outcome Measures

Name	Time	Method
Postoperative sedation level	1st 2 hours postoperatively	Assessment of postoperative sedation level using "University of Michigan Sedation Scale (UMSS)" The UMSS is a simple observational tool that assesses the level of alertness on a five-point scale ranging from 1 (wide awake) to 5 (unarousable with deep stimulation). Score: 1- 5
Recovery time in minutes	At the end of operation	Recovery time in minutes (time interval between discontinuation of isoflurane and extubation).

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt