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Head Position on Preventing Emergence Cough

Primary Purpose

Gallbladder Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Head on bed
Head on pillow
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gallbladder Diseases

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Operation schedule of laparoscopic cholecystectomy
  • Must be performed under general anesthesia

Exclusion Criteria:

  • BMI > 30 kg/m2
  • Respiratory infection
  • Uncontrolled hypertension

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Ajou University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control group

Head elevation group

Arm Description

The endotracheal extubation is performed in head on bed without pillow.

The endotracheal extubation is performed in head elevation on pillow (slight flextion of neck on chest) .

Outcomes

Primary Outcome Measures

The severity of cough
0: no cough, 1:single 2: more than one episode of non-sustained cough, 3: sustained and repetitive cough

Secondary Outcome Measures

Full Information

First Posted
May 25, 2020
Last Updated
October 21, 2021
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04409652
Brief Title
Head Position on Preventing Emergence Cough
Official Title
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of head position on prevent the emergence cough followed by endotracheal extubation.
Detailed Description
During endotrachl intubaion, the sniffing postion is most commonly recommended. However, the head position to reduce the emergence cough followed by endotracheal extubation was not confirmed yet. Considering the endotracheal tube vector, head elevation with pillow is thought to be acceptable more.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The endotracheal extubation is performed in head on bed without pillow.
Arm Title
Head elevation group
Arm Type
Active Comparator
Arm Description
The endotracheal extubation is performed in head elevation on pillow (slight flextion of neck on chest) .
Intervention Type
Procedure
Intervention Name(s)
Head on bed
Intervention Description
During emergence, head is kept on bed without pillow.
Intervention Type
Procedure
Intervention Name(s)
Head on pillow
Intervention Description
During emergence, head is kept on pillow.
Primary Outcome Measure Information:
Title
The severity of cough
Description
0: no cough, 1:single 2: more than one episode of non-sustained cough, 3: sustained and repetitive cough
Time Frame
during extubation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Operation schedule of laparoscopic cholecystectomy Must be performed under general anesthesia Exclusion Criteria: BMI > 30 kg/m2 Respiratory infection Uncontrolled hypertension
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Eun Kim
Phone
82-31-219-5575
Email
beye98@aumc.ac.kr

12. IPD Sharing Statement

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Head Position on Preventing Emergence Cough

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