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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04607525
Other study ID # R 115 / 2020
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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