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Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy

NCT04607525 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-03-01

No results posted yet for this study

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

Conditions

  • Hemodynamic Instability
  • Supratentorial Neoplasms

Interventions

DRUG

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 \[5\] \[6\] \[7\].

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-21
Primary Completion
2021-01-20
Completion
2021-01-26

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04607525 on ClinicalTrials.gov