NCT05626998

Brief Summary

To compare the effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

November 8, 2022

Last Update Submit

August 29, 2023

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • emergence agitation (EA)

    in the form of Riker Sedation-Agitation Scale (where 1 = "unarousable" and 7 = "dangerous agitation" with score ≥5 considered EA).

    During first hour of recovery.

Secondary Outcomes (2)

  • Postoperative pain in the form of visual analog scale

    every 4 hours for 12 hours

  • Incidence of the common adverse effects

    at 12 hours

Study Arms (3)

Control

NO INTERVENTION

The participants will not receive premedication

Dexmedetomidine

ACTIVE COMPARATOR

The participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward

Drug: Dexmedetomidine

Gabapentin

ACTIVE COMPARATOR

The participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward

Drug: Gabapentin

Interventions

DexmedetomidineDRUG

The participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward.

Dexmedetomidine
GabapentinDRUG

The participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward

Gabapentin

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists grade I or II.
  • Sex: Both sexes.
  • Age between 18 and 40 years.
  • Patients scheduled for rhinoplasty under general anesthesia

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine, Ain Shams University

Cairo, 11591, Egypt

Location

Related Publications (1)

  • Abdelaziz TSA, Mohammed Elsayed HE, Kamal Eldin DM, Ibrahim IM. "The effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty". A prospective, randomized, double-blind controlled trial. BMC Anesthesiol. 2025 Jan 31;25(1):50. doi: 10.1186/s12871-025-02914-5.

    PMID: 39891093DERIVED

MeSH Terms

Interventions

DexmedetomidineGabapentin

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • tamer S abdelaziz, MD

    Faculty of medicine, Ain Shams University, Cairo, Egypt

    PRINCIPAL INVESTIGATOR

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
lecturer of Anesthesia

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 25, 2022

Study Start

November 1, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

EG(1)