Dexmedetomidine Versus Ketamine on Laryngeal Microsurgery | NCT07048873

Studies
Dexmedetomidine Versus Ketamine on Laryngeal Microsurgery

NCT07048873

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jul 3, 2025Actual

Enrollment

168Actual

Phase

Not Applicable

Conditions

Microlaryngeal Surgery

Interventions

Dexmedetomidine
Ketamine
Saline (control group)

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2024Actual

Primary Completion Date

Jun 20, 2024Actual

Completion Date

Jun 30, 2024Actual

First Submitted Date

May 5, 2024

First Submission Date that Met QC Criteria

Jun 30, 2025

First Posted Date

Jul 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2025

Last Update Posted Date

Jul 3, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dalia Ismail, Associate Professor of Anesthesia, Surgical ICU and pain management at Faculty of medicine Cairo University, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Microlaryngeal surgery is a common surgical procedure now a days which is associated with many complications such as postoperative pain, airway edema and persistent cough

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

168Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	IV dexmedetomidine	Dexmedetomidine
Ketamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of postoperative sore throat	incidence of postoperative sore throat	30 minutes postoperative

Secondary Outcomes

Measure	Description	Time Frame
Ramsey sedation score	Ramsey sedation score RSS (1 to 6)	1hour postoperative
postoperative cough incidence	postoperative cough incidence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 18-70 years ASA I,II

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine Cairo university		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D007649	Ketamine
D012965	Sodium Chloride
D035061	Control Groups

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided