Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy

Study Overview
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Brief Summary
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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
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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

Official Title
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Efficacy of Dexmedetomidine Infusion Without Loading Dose on Hemodynamic Variables and Recovery Time During Craniotomy: A Randomized Double Blinded Controlled Study

Conditions
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Hemodynamic Instability, Supratentorial Neoplasms

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group D<br>Group D: Patients received 0.5 µg/kg/h of Dexmedetomidine. Dexmedetomidine dosage was diluted in 50 ml syringe of normal saline | Drug: Dexmedetomidine<br>* 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].<br>|
| Placebo Comparator: Group C<br>Patients received equal volume and rate of normal saline as Group D. | Drug: normal saline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean areterial blood pressure | incidence of intraoperative hemodynamic stability | 4 to 8 hours | 
| Heart rate | incidence of intraoperative hemodynamic stability | 4 to 8 hours | 
| Number of Participants needed rescue agents |  | 4 to 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery time in minutes | Recovery time in minutes (time interval between discontinuation of isoflurane and extubation). | 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 | 1st 2 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative analgesia, Craniotomy, Dexmedetomidine