TIVA Versus Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery

NCT ID: NCT03727607

Last Updated: 2018-11-01

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

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-30

Study Completion Date

2018-03-14

Brief Summary

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Many factors during laparascopic surgery leads to PONV (postoperative nausea and vomiting), such as C02 insufflations causing peritoneal stretch and irritation and type of anaesthesia given during surgery.

The two anesthetic techniques used in bariatric surgery are gas anesthesia (Remifentanil TCI and Desfluran) and Total Intra Venous Anesthesia (TIVA) with propofol. There are studies which have shown a reduction in postoperative nausea and vomiting following TIVA, and there are publications showing no statistically significant difference.

The aim of this study was to investigate the best anaesthetic approach for obese subjects, evaluating awakening time, postoperative nausea and pain.

Our hypothesis was based on the fact that Propofol is a lipid-soluble anesthetic and therefore might have a prolonged effect in obese patients, leading to a longer awakening time along with postoperative nausea and vomiting. This hypothesis is also described earlier by obese patients have more depots (bulk fat) and also more fat surface making anaesthetics storage more easier, and also that the anesthetic will return into the circulation when the administration is stopped \[18\].

Detailed Description

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Conditions

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Total Intravenous Anesthesia Desflurane Obesity Pain, Postoperative Nausea, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized control trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Gass

DESFLURANE ANESTHESIA

Group Type ACTIVE_COMPARATOR

Desflurane

Intervention Type DRUG

Desflurane vs TIVA, bariatric surgery. Postoperative nausea and pain

TIVA

TOTAL INTRAVENOUS ANESTHESIA

Group Type ACTIVE_COMPARATOR

Desflurane

Intervention Type DRUG

Desflurane vs TIVA, bariatric surgery. Postoperative nausea and pain

Interventions

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Desflurane

Desflurane vs TIVA, bariatric surgery. Postoperative nausea and pain

Intervention Type DRUG

Other Intervention Names

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PROPOFOL

Eligibility Criteria

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Inclusion Criteria

* BMI ≥35 kg/m2 with at least one comorbid condition or BMI ≥40 kg/m2.

Exclusion Criteria

* drug abuse
* severe mental illness
* age\<18
* serious medical condition; cancer, end-stage lung disease (ASA\>3) or allergies to any drugs used in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ostfold Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2016/1659

Identifier Type: -

Identifier Source: org_study_id

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