NCT07355049

Brief Summary

The effect of intravenous dexmedetomidine versus intravenous lidocaine on the emergence agitation after endoscopic sinus surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

November 15, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

December 21, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

November 15, 2025

Last Update Submit

January 20, 2026

Conditions

Emergence Agitation

Keywords

Emergence agitationIntravenous dexmedetomidineEndoscopic sinus surgeryIntravenous lidocaine

Outcome Measures

Primary Outcomes (1)

  • Incidence of emergence agitation (EA) .

    Incidence of emergence agitation (EA) as measured by Richmond Agitation Sedation Scale (RASS) .

    Immediate after extubation

Secondary Outcomes (29)

  • heart rate (beats per minute )

    baseline ( preoperative )

  • heart rate (beats per minute )

    after 30 minutes ( intraoperative)

  • heart rate (beats per minute)

    after 60 minutes ( intraoperative )

  • heart rate (beats per minute)

    0 hour postoperative

  • heart rate (beats per minute)

    1 hour postoperative

  • +24 more secondary outcomes

Study Arms (2)

Group L

ACTIVE COMPARATOR

Active comparator group Group (L) recieves IV lidocaine 1.5mg/kg slowly before induction of anesthesia then lidocaine infusion starts at a rate of 2mg/kg/h

Drug: Lidocaine

Group D

ACTIVE COMPARATOR

Active comparator group (D) recieves IV dexmedetomidine bolus dose of 1mcg/kg over 10 minutes before induction of anesthesia followed by continous infusion at 0.4mcg/kg/h until the end of surgery

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Group (D) recieves Dexmedetomidine bolus 1mcg/kg over 10 minutes before induction of anesthesia followed by continous infusion at 0.4 mcg/kg/h until the end of surgery

Group D
LidocaineDRUG

Group (L) recieves IV lidocaine 1.5 mg/kg slowly before induction of anesthesia then lidocaine infusion starts at a rate of 2mg/kg/h

Group L

Eligibility Criteria

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

You may qualify if:

  • Age : 18-60
  • ASA Physical Status I or II
  • Elective endoscopic sinus surgery under general anesthesia .

You may not qualify if:

  • Refusal to participate
  • Mental retardation or inability to communicate
  • Allergy to anesthetics or study medications .
  • Chronic use of beta blockers .
  • significant hepatic, neurologic, cardiovascular or respiratory disease .
  • BMI\>35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FayoumU

Al Fayyum, 63511, Egypt

Location

Related Publications (2)

  • Mohkamkar M Bs, Farhoudi F Md, Alam-Sahebpour A Md, Mousavi SA Md, Khani S PhD, Shahmohammadi S BSc. Postanesthetic Emergence Agitation in Pediatric Patients under General Anesthesia. Iran J Pediatr. 2014 Apr;24(2):184-90.

    PMID: 25535538RESULT

  • Lourijsen ES, Reitsma S, Vleming M, Hannink G, Adriaensen GFJPM, Cornet ME, Hoven DR, Videler WJM, Bretschneider JH, Reinartz SM, Rovers MM, Fokkens WJ. Endoscopic sinus surgery with medical therapy versus medical therapy for chronic rhinosinusitis with nasal polyps: a multicentre, randomised, controlled trial. Lancet Respir Med. 2022 Apr;10(4):337-346. doi: 10.1016/S2213-2600(21)00457-4. Epub 2022 Jan 7.

    PMID: 35012708RESULT

MeSH Terms

Conditions

Emergence Delirium

Interventions

DexmedetomidineLidocaine

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Khaled E Tolba, MBBCH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Khaled E Tolba, MBBCH

CONTACT

01002568304ket11@fayoum.edu.eg

Mohamed A Hamed, MD

CONTACT

01010509736

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 15, 2025

First Posted

January 21, 2026

Study Start

December 21, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)