NCT07504497

Brief Summary

compare the efficacy of intratracheal dexmedetomidine versus intratracheal lidocaine in achieving smooth tracheal extubation in patients undergoing Functional Endoscopic Sinus surgery and reconstructive nasal surgeries under general anesthesia.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
7mo left

Started Apr 2026

Shorter than P25 for phase_4

Status
not yet recruiting

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

Study Progress16%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

March 22, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 22, 2026

Last Update Submit

March 26, 2026

Conditions

FESS Operation

Outcome Measures

Primary Outcomes (1)

  • Quality of extubation assessed by cough score at extubation . scored 0-5: 0 = No cough 1 = Occasional, single cough 2 = Mild, does not interfere with activities 3 = Moderate, interferes with activities 4 = Severe 5 = very sever. 0 is better 5 is worst

    at time of extubation

Study Arms (3)

Dexmedetomidine Group

EXPERIMENTAL

patients receive Intratracheal dexmedetomidine 0.5 µg/kg diluted to 4 mL with normal saline

Drug: dexmedetomidine Lidocaine Saline

Lidocaine Group

ACTIVE COMPARATOR

patients receive Intratracheal lidocaine hydrochloride 2% 1.5 mg/kg (4 mL) (6,8).

Drug: dexmedetomidine Lidocaine Saline

Saline group

PLACEBO COMPARATOR

patient receive 4 mL of normal saline

Drug: dexmedetomidine Lidocaine Saline

Interventions

dexmedetomidine Lidocaine SalineDRUG

At the end of the surgery , the endotracheal tube cuff will be deflated and the study drug will be administered intratracheally. Manual positive pressure ventilation will be applied for drug distribution, followed by cuff reinflation

Dexmedetomidine GroupLidocaine GroupSaline group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Age 18-60 years.
  • Elective FESS under general anesthesia.
  • ASA Physical Status I-II

You may not qualify if:

  • Allergy to dexmedetomidine or lidocaine
  • Anticipated difficult airway
  • Chronic pulmonary diseases (asthma, COPD)
  • Uncontrolled hypertension or ischemic heart disease
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

youness ahmed youness, resident doctor

CONTACT

01121614761younessahmeh@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
anesthesia resident

Study Record Dates

First Submitted

March 22, 2026

First Posted

March 31, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share