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NCT Number: NCT04607525

Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy

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

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Key information

Conditions

Hemodynamic Instability Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Supratentorial Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University Hospitals

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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 saline

Drug

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.

Primary outcomes

  1. Mean areterial blood pressure

    Time frame: 4 to 8 hours

    incidence of intraoperative hemodynamic stability

  2. Heart rate

    Time frame: 4 to 8 hours

    incidence of intraoperative hemodynamic stability

  3. Number of Participants needed rescue agents

    Time frame: 4 to 8 hours

Secondary outcomes

  1. Recovery time in minutes

    Time frame: At the end of operation

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

  2. Postoperative sedation level

    Time frame: 1st 2 hours postoperatively

    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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2020
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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