Back to resultsDexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty
Primary Purpose
Anesthesia
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Gabapentin
Sponsored by
About this trial
This is an interventional prevention trial for Anesthesia
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists grade I or II. Sex: Both sexes. Age between 18 and 40 years. Patients scheduled for rhinoplasty under general anesthesia Exclusion Criteria: Declining to give written informed consent. History of allergy to the medications used in the study. history of cardiovascular diseases including bradycardia, heart block, and hypertension. History of chest problems including bronchial asthma. Had a history of drug or alcohol abuse. Taking opioids or sedative medications. Inability to communicate with patients to evaluate postoperative pain. Hepatic or renal failure. Psychiatric disorders with antipsychotics or antidepressants. Bleeding disorders, antiplatelets (aspirin, clopidogrel), or anticoagulant (warfarin).
Sites / Locations
- faculty of medicine, Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control
Dexmedetomidine
Gabapentin
Arm Description
The participants will not receive premedication
The participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward
The participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward
Outcomes
Primary Outcome Measures
emergence agitation (EA)
in the form of Riker Sedation-Agitation Scale (where 1 = "unarousable" and 7 = "dangerous agitation" with score ≥5 considered EA).
Secondary Outcome Measures
Postoperative pain in the form of visual analog scale
(VAS, 0=no pain; 10=worst possible pain)
Incidence of the common adverse effects
nausea and vomiting, dizziness, and headache
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05626998
Brief Title
Dexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty
Official Title
The Effect of Intramuscular Dexmedetomidine Versus Oral Gabapentin Premedication on the Emergence Agitation After Rhinoplasty. A Prospective, Randomized, Double-blind Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (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
5. Study Description
Brief Summary
To compare the effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty.
Detailed Description
Emergence agitation (EA) is a clinical condition characterized by agitation, confusion, disorientation, and aggressive behavior in the early phase of recovery from general anesthesia (incidence about 21.3%). This may lead to various injuries, self-extubation, bleeding, increased pain, removal of catheters, increased blood pressure, heart rate, and myocardial oxygen consumption. Premedication with dexmedetomidine and gabapentin are promising options for EA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
The participants will not receive premedication
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
The participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward
Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
The participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
The participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
The participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward
Primary Outcome Measure Information:
Title
emergence agitation (EA)
Description
in the form of Riker Sedation-Agitation Scale (where 1 = "unarousable" and 7 = "dangerous agitation" with score ≥5 considered EA).
Time Frame
During first hour of recovery.
Secondary Outcome Measure Information:
Title
Postoperative pain in the form of visual analog scale
Description
(VAS, 0=no pain; 10=worst possible pain)
Time Frame
every 4 hours for 12 hours
Title
Incidence of the common adverse effects
Description
nausea and vomiting, dizziness, and headache
Time Frame
at 12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists grade I or II.
Sex: Both sexes.
Age between 18 and 40 years.
Patients scheduled for rhinoplasty under general anesthesia
Exclusion Criteria:
Declining to give written informed consent.
History of allergy to the medications used in the study.
history of cardiovascular diseases including bradycardia, heart block, and hypertension.
History of chest problems including bronchial asthma.
Had a history of drug or alcohol abuse.
Taking opioids or sedative medications.
Inability to communicate with patients to evaluate postoperative pain.
Hepatic or renal failure.
Psychiatric disorders with antipsychotics or antidepressants.
Bleeding disorders, antiplatelets (aspirin, clopidogrel), or anticoagulant (warfarin).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tamer S abdelaziz, MD
Organizational Affiliation
Faculty of medicine, Ain Shams University, Cairo, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of medicine, Ain Shams University
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Dexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty
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