Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy

NCT04607525 | Completed Phase 4 DMC

• 1 other identifier: R 115 / 2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hemodynamic Instability; Supratentorial Neoplasms

Keywords

Postoperative analgesia; Craniotomy; Dexmedetomidine

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Recovery time in minutes

  At the end of operation

• Postoperative sedation level

  1st 2 hours postoperatively

Study Arms (2)

Group D

EXPERIMENTAL

Group D: Patients received 0.5 µg/kg/h of Dexmedetomidine. Dexmedetomidine dosage was diluted in 50 ml syringe of normal saline

Drug: Dexmedetomidine

Group C

PLACEBO COMPARATOR

Patients received equal volume and rate of normal saline as Group D.

Drug: normal saline

Interventions

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 \[5\] \[6\] \[7\].

Group D

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.

Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American society of anesthesiologists- Physical status (ASA-PS) I and II patients,
• aged 18 to 65 years
• both sexes
• undergoing elective supratentorial craniotomy for tumor resection

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Supratentorial Neoplasms

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 29, 2020
• Study Start: November 21, 2020
• Primary Completion: January 20, 2021
• Study Completion: January 26, 2021
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After completion of the study till 1 year
• Access Criteria: Via email request

Locations

EG (1)