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TIVA Versus Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03727607
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Ostfold Hospital Trust

Brief Summary:

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].


Condition or disease Intervention/treatment Phase
Total Intravenous Anesthesia Desflurane Obesity Pain, Postoperative Nausea, Postoperative Drug: Desflurane Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized control trial.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial - Total Intravenous Anaesthesia Versus Inhaled Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery. Postoperative Pain and Nausea
Actual Study Start Date : January 30, 2016
Actual Primary Completion Date : December 11, 2017
Actual Study Completion Date : March 14, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Desflurane

Arm Intervention/treatment
Active Comparator: Gass
DESFLURANE ANESTHESIA
Drug: Desflurane
Desflurane vs TIVA, bariatric surgery. Postoperative nausea and pain
Other Name: PROPOFOL

Active Comparator: TIVA
TOTAL INTRAVENOUS ANESTHESIA
Drug: Desflurane
Desflurane vs TIVA, bariatric surgery. Postoperative nausea and pain
Other Name: PROPOFOL




Primary Outcome Measures :
  1. Awakening time after surgery [ Time Frame: 2 hours postdose ]
    time noted from anaesthesia stoped to patients awake

  2. Degree of nausea and vomiting after surgery [ Time Frame: 48 hours postsurgery ]
    Noted using NRS scale (from 0-10)

  3. Degree of pain after surgery [ Time Frame: 48 hours post surgery ]
    Noted using NRS scale (from 0-10)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT03727607    
Other Study ID Numbers: 2016/1659
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nausea
Pain, Postoperative
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Vomiting
Anesthetics
Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, General
Anesthetics, Inhalation