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Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy

Primary Purpose

Hemodynamic Instability, Supratentorial Neoplasms

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
normal saline
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemodynamic Instability focused on measuring Postoperative analgesia, Craniotomy, Dexmedetomidine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ain Shams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group D

Group C

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean areterial blood pressure
incidence of intraoperative hemodynamic stability
Heart rate
incidence of intraoperative hemodynamic stability
Number of Participants needed rescue agents

Secondary Outcome Measures

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

Full Information

First Posted
October 19, 2020
Last Updated
February 26, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04607525
Brief Title
Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy
Official Title
Efficacy of Dexmedetomidine Infusion Without Loading Dose on Hemodynamic Variables and Recovery Time During Craniotomy: A Randomized Double Blinded Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 21, 2020 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
January 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodynamic Instability, Supratentorial Neoplasms
Keywords
Postoperative analgesia, Craniotomy, Dexmedetomidine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group D
Arm Type
Experimental
Arm Description
Group D: Patients received 0.5 µg/kg/h of Dexmedetomidine. Dexmedetomidine dosage was diluted in 50 ml syringe of normal saline
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Patients received equal volume and rate of normal saline as Group D.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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].
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
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 Outcome Measure Information:
Title
Mean areterial blood pressure
Description
incidence of intraoperative hemodynamic stability
Time Frame
4 to 8 hours
Title
Heart rate
Description
incidence of intraoperative hemodynamic stability
Time Frame
4 to 8 hours
Title
Number of Participants needed rescue agents
Time Frame
4 to 8 hours
Secondary Outcome Measure Information:
Title
Recovery time in minutes
Description
Recovery time in minutes (time interval between discontinuation of isoflurane and extubation).
Time Frame
At the end of operation
Title
Postoperative sedation level
Description
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
Time Frame
1st 2 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy

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