Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607525
• Other study ID #: R 115 / 2020
• Status: Completed
• Phase: Phase 4
• Start date: November 21, 2020
• Est. completion date: January 26, 2021

Study information

• Verified date: February 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 26, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability
• Supratentorial Neoplasms

Intervention

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].
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean areterial blood pressure	incidence of intraoperative hemodynamic stability	4 to 8 hours
Primary	Heart rate	incidence of intraoperative hemodynamic stability	4 to 8 hours
Primary	Number of Participants needed rescue agents		4 to 8 hours
Secondary	Recovery time in minutes	Recovery time in minutes (time interval between discontinuation of isoflurane and extubation).	At the end of operation
Secondary	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