NCT05313659

Brief Summary

Emergence agitation (EA) is a common complication after nasal surgery. In this study, we aimed to investigate the effect of intramuscular ketamine on EA following septoplasty and open septorhinoplasty (OSRP) when administered at subanesthetic doses at the end of surgery. Sedation and Agitation scores were recorded using The Richmond agitation-sedation score after extubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
193

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2022

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 11, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

March 20, 2022

Last Update Submit

January 23, 2023

Conditions

Agitation, Emergence

Keywords

AgitationEmergenceKetamineIntramuscularNasal surgery

Outcome Measures

Primary Outcomes (1)

  • Development of Agitation

    Using The Richmond agitation-sedation score. The score being from(-5) to (+4) ; 2 and more being agitated patients and less than 2 not agitated.

    immediately After extubation.

Study Arms (2)

group-K

EXPERIMENTAL

At the end of surgery and immediately after the inhalational agent was discontinued, 2mL of normal saline containing 0.7 mg/kg racemic ketamine was administered intramuscularly to Group-K

Drug: Ketamine Hydrochloride

group-S

NO INTERVENTION

At the end of surgery and immediately after the inhalational agent was discontinued, 2 mL of normal saline was administered intramuscularly.

Interventions

Ketamine HydrochlorideDRUG

intramuscular ketamine hydrochloride at dose of 0.7 mg/kg at the time of turning the inhalational agent off

group-K

Eligibility Criteria

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

You may qualify if:

  • Age group 18-64 years old
  • ASA I-II
  • BMI 20-29.9
  • Patients accepting the study and consenting
  • Undergoing general anesthesia for scheduled septoplasty or open septorhinoplasty.

You may not qualify if:

  • ketamine allergy
  • Morphine allergy
  • History of cardiac, neurological, or psychiatric disease, glaucoma,
  • Patients with a body mass index of less than 20 or more than 30 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordanian Royal Medical Services

Amman, 11855, Jordan

Location

MeSH Terms

Conditions

Emergence DeliriumPsychomotor Agitation

Interventions

Ketamine

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersDyskinesiasPsychomotor DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Husam A. Almajali, MD

    Jordanian Royal Medical Services

    PRINCIPAL INVESTIGATOR

  • Ali M. Abu Dalo, MD

    Jordanian Royal Medical Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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
anesthesia specialist

Study Record Dates

First Submitted

March 20, 2022

First Posted

April 6, 2022

Study Start

May 11, 2022

Primary Completion

October 20, 2022

Study Completion

October 20, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

JO(1)