Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy

Ain Shams University40 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Hemodynamic Instability Supratentorial Neoplasms

Interventions

DexmedetomidineDRUG

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

normal salineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Ain Shams University Hospitals

Cairo, Egypt

Outcomes

Primary Outcomes

Mean areterial blood pressure

incidence of intraoperative hemodynamic stability

Time frame: 4 to 8 hours

Heart rate

incidence of intraoperative hemodynamic stability

Time frame: 4 to 8 hours

Number of Participants needed rescue agents

Time frame: 4 to 8 hours

Secondary Outcomes

Recovery time in minutes

Recovery time in minutes (time interval between discontinuation of isoflurane and extubation).

Time frame: At the end of operation

Postoperative sedation level

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

Time frame: 1st 2 hours postoperatively

Data from ClinicalTrials.gov

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