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Mild Intraoperative Hyperventilation to Decrease Post-op. Shoulder Pain After LSG

Primary Purpose

Laparoscopic Gastric Sleeve Surgery, ASA-I and II Risk Class Patients, Same Surgeon

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
mild intraoperative hyperventilation
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Gastric Sleeve Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years old
  • No mental illnesses
  • American Society of Anesthesiologists (ASA) class I&II,
  • Patients undergoing laparoscopic sleeve gastrectomy.
  • No previous intrabdominal surgeries.

Exclusion Criteria:

  • ASA class >II,
  • previous abdominal surgeries.
  • mental illnesses.

Sites / Locations

  • King Abdullah Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mild Hyperventilation

Control

Arm Description

In this study arm, patients were mildly hyperventilated intraoperatively so their end-tidal CO2 levels are brought down to 30-32 mmHg.

In this study arm patients' ventilation is managed according to guidelines with end-tidal CO2 levels kept in the normal range of 35-40 mm Hg

Outcomes

Primary Outcome Measures

Postoperative shoulder Pain
patient complaining of left of right shoulder pain after laparoscopic sleeve gastrectomy will be evaluated using numerical rating scale, were zero indicates no pain at all, and 10 indicates most severe pain the patient has ever had.

Secondary Outcome Measures

Postoperative nausea and vomiting
The development of nausea and vomiting among patients after laparoscopic sleeve gastrectomy.

Full Information

First Posted
August 9, 2020
Last Updated
August 17, 2020
Sponsor
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04514887
Brief Title
Mild Intraoperative Hyperventilation to Decrease Post-op. Shoulder Pain After LSG
Official Title
Intraoperative Mild Hyperventilation as an Intervention to Decrease the Incidence of Postoperative Shoulder Pain After Gastric Sleeve Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 16, 2019 (Actual)
Primary Completion Date
February 2, 2020 (Actual)
Study Completion Date
February 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jordan University of Science and Technology

4. Oversight

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

5. Study Description

Brief Summary
Shoulder pain is common after laparoscopic surgeries. multiple maneuvers are in use to decrease its incidence with variable results. This study aims to investigate the effect of mild hyperventilation to an End-tidal CO2 level of 30-32 mmHg on the occurrence of postoperative shoulder pain. This is carried out through a comparison of the incidence of postoperative shoulder pain an intervention group to that in a control one with a normal End Tidal CO2 35-40 mmHg). controlling for all other variables.
Detailed Description
This novel technique is based on the theory that shoulder pain is caused by diaphragmatic irritation by CO2 during laparoscopic surgery. The investigators postulate that lowering the CO2 level in the plasma, will lower tissue CO2 level in the diaphragm and decrease the hypothesized irritation. In this study, patients will be divided into an interventional group which will receive mild intraoperative hyperventilation determined by an End-Tidal CO2 level of 30-32 mm Hg and a control group in which End Tidal CO2 is kept at normal levels (35-40 mmHg). All other intraoperative factors will be standardized for all patients. Patients will be followed up postoperatively and asked whether the participants developed shoulder pain as a primary study outcome. The pain will be recorded in terms of severity, site, and position, and any associations (Nausea and vomiting). Appropriate statistical tests will be used to check for any significant effects of the technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Gastric Sleeve Surgery, ASA-I and II Risk Class Patients, Same Surgeon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Only the anesthetist administering the anesthesia and mechanical ventilation is Awarem of the arm.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mild Hyperventilation
Arm Type
Experimental
Arm Description
In this study arm, patients were mildly hyperventilated intraoperatively so their end-tidal CO2 levels are brought down to 30-32 mmHg.
Arm Title
Control
Arm Type
No Intervention
Arm Description
In this study arm patients' ventilation is managed according to guidelines with end-tidal CO2 levels kept in the normal range of 35-40 mm Hg
Intervention Type
Other
Intervention Name(s)
mild intraoperative hyperventilation
Intervention Description
Intraoperative mechanical ventilation of patients was adjusted so that end-tidal CO2 readings lie between 30-32 mmHg
Primary Outcome Measure Information:
Title
Postoperative shoulder Pain
Description
patient complaining of left of right shoulder pain after laparoscopic sleeve gastrectomy will be evaluated using numerical rating scale, were zero indicates no pain at all, and 10 indicates most severe pain the patient has ever had.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Postoperative nausea and vomiting
Description
The development of nausea and vomiting among patients after laparoscopic sleeve gastrectomy.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years old No mental illnesses American Society of Anesthesiologists (ASA) class I&II, Patients undergoing laparoscopic sleeve gastrectomy. No previous intrabdominal surgeries. Exclusion Criteria: ASA class >II, previous abdominal surgeries. mental illnesses.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adel M Bataineh, MD
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Abdullah Teaching Hospital
City
Irbid
ZIP/Postal Code
22110
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31517775
Citation
Sao CH, Chan-Tiopianco M, Chung KC, Chen YJ, Horng HC, Lee WL, Wang PH. Pain after laparoscopic surgery: Focus on shoulder-tip pain after gynecological laparoscopic surgery. J Chin Med Assoc. 2019 Nov;82(11):819-826. doi: 10.1097/JCMA.0000000000000190.
Results Reference
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PubMed Identifier
23340814
Citation
Donatsky AM, Bjerrum F, Gogenur I. Surgical techniques to minimize shoulder pain after laparoscopic cholecystectomy. A systematic review. Surg Endosc. 2013 Jul;27(7):2275-82. doi: 10.1007/s00464-012-2759-5. Epub 2013 Jan 24.
Results Reference
background
PubMed Identifier
25361653
Citation
Pergialiotis V, Vlachos DE, Kontzoglou K, Perrea D, Vlachos GD. Pulmonary recruitment maneuver to reduce pain after laparoscopy: a meta-analysis of randomized controlled trials. Surg Endosc. 2015 Aug;29(8):2101-8. doi: 10.1007/s00464-014-3934-7. Epub 2014 Nov 1.
Results Reference
background
PubMed Identifier
18448749
Citation
Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.
Results Reference
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Mild Intraoperative Hyperventilation to Decrease Post-op. Shoulder Pain After LSG

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