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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-16

Study Completion Date

2020-02-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Only the anesthetist administering the anesthesia and mechanical ventilation is Awarem of the arm.

Study Groups

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Mild Hyperventilation

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

Group Type EXPERIMENTAL

mild intraoperative hyperventilation

Intervention Type OTHER

Intraoperative mechanical ventilation of patients was adjusted so that end-tidal CO2 readings lie between 30-32 mmHg

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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