Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Hemodynamic Instability; Supratentorial Neoplasms

Treatments: Drug: normal saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04607525

R 115 / 2020

Details and patient eligibility

About

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

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Group D

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine

Group C

Placebo Comparator group

Description:

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

Treatment:

Drug: normal saline