NCT07048873

Brief Summary

compare effect of IV dexmedetomidine and ketamine on pain score, perioperative hemodynamics and detect side effects of dexmedetomidine and ketamine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

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

January 10, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
1 year until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

May 5, 2024

Last Update Submit

June 30, 2025

Conditions

Microlaryngeal Surgery

Outcome Measures

Primary Outcomes (1)

  • incidence of postoperative sore throat

    incidence of postoperative sore throat

    30 minutes postoperative

Secondary Outcomes (6)

  • Ramsey sedation score

    1hour postoperative

  • postoperative cough incidence

    1hour postoperative

  • incidence of complications

    1hour postoperative

  • Heart Rate

    1hour postoperative

  • Mean Arterial Pressure

    1hour postoperative

  • +1 more secondary outcomes

Study Arms (3)

Dexmedetomidine

EXPERIMENTAL

1.0mcg/kg of dexmedetomidineloading dose before induction then 0.5 mcg/kg/hr of infused till end of surgery

Drug: Dexmedetomidine

Ketamine

EXPERIMENTAL

0.25 mg/kg/hr ketamine infused till end of surgery

Drug: Ketamine

Control

ACTIVE COMPARATOR

saline before induction infusion till end of surgery

Drug: Saline (control group)

Interventions

DexmedetomidineDRUG

IV dexmedetomidine

Dexmedetomidine
KetamineDRUG

IV ketamine

Ketamine
Saline (control group)DRUG

no drugs

Also known as: NO drugs
Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18-70 years ASA I,II

You may not qualify if:

  • CVdiseases as IHD and severe valvular disease.
  • allergy to ketamine or dexmedetomidine.
  • Patients refusal
  • Suspected difficult intubation more than 2 trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Cairo university

Cairo, Egypt

Location

MeSH Terms

Interventions

DexmedetomidineKetamineSodium ChlorideControl Groups

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesia, Surgical ICU and pain management at Faculty of medicine Cairo University

Study Record Dates

First Submitted

May 5, 2024

First Posted

July 3, 2025

Study Start

January 10, 2024

Primary Completion

June 20, 2024

Study Completion

June 30, 2024

Last Updated

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)