Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy

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

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

Study Overview

• Status: Completed
• Conditions: Supratentorial Neoplasms; Hemodynamic Instability
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: normal saline

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2020
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): January 26, 2021

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Postoperative analgesia; Craniotomy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Supratentorial Neoplasms; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: R 115 / 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: After completion of the study till 1 year
• IPD Sharing Access Criteria: Via email request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No