NCT04371094

Brief Summary

This is a prospective double-blinded clinical trial aiming to compare the incidence and severity of sore throat after laparoscopic cholecystectomy when using two different techniques of intubation using glidescope

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

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 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

April 27, 2020

Last Update Submit

September 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative sore throat (POST)

    report severity of postoperative sore throat and CHANGES that could occur later on

    IMMEDIATELY POSTOPERATIVE AND 2 HORSE LATER

Secondary Outcomes (1)

  • postoperative sore throat (POST)

    immediately postoperative at recovery room

Study Arms (2)

stylet

ACTIVE COMPARATOR

The stylet is a device that is put inside the endotracheal tube to facilitate its insertion into the trachea

Device: a device to facilitate endotracheal intubation

bougie

ACTIVE COMPARATOR

The bougie is a device that is inserted into the trachea and an endotracheal tube is loaded over it and is slide into the trachea

Device: a device to facilitate endotracheal intubation

Interventions

a device to facilitate endotracheal intubation

bougiestylet

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I, II UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GA

You may not qualify if:

  • ANTICIPATED DIFFICULT INTUBATION

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
double-blinded
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and intensive care

Study Record Dates

First Submitted

April 27, 2020

First Posted

May 1, 2020

Study Start

January 1, 2020

Primary Completion

March 30, 2020

Study Completion

May 30, 2021

Last Updated

September 29, 2022

Record last verified: 2022-09

Locations