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TIVA Versus Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery

Primary Purpose

Total Intravenous Anesthesia, Desflurane, Obesity

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Desflurane
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Intravenous Anesthesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Gass

    TIVA

    Arm Description

    DESFLURANE ANESTHESIA

    TOTAL INTRAVENOUS ANESTHESIA

    Outcomes

    Primary Outcome Measures

    Awakening time after surgery
    time noted from anaesthesia stoped to patients awake
    Degree of nausea and vomiting after surgery
    Noted using NRS scale (from 0-10)
    Degree of pain after surgery
    Noted using NRS scale (from 0-10)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 14, 2018
    Last Updated
    October 31, 2018
    Sponsor
    Ostfold Hospital Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03727607
    Brief Title
    TIVA Versus Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery
    Official Title
    A Randomized Controlled Trial - Total Intravenous Anaesthesia Versus Inhaled Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery. Postoperative Pain and Nausea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 30, 2016 (Actual)
    Primary Completion Date
    December 11, 2017 (Actual)
    Study Completion Date
    March 14, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ostfold Hospital Trust

    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
    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].

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Total Intravenous Anesthesia, Desflurane, Obesity, Pain, Postoperative, Nausea, Postoperative

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized control trial.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    160 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Gass
    Arm Type
    Active Comparator
    Arm Description
    DESFLURANE ANESTHESIA
    Arm Title
    TIVA
    Arm Type
    Active Comparator
    Arm Description
    TOTAL INTRAVENOUS ANESTHESIA
    Intervention Type
    Drug
    Intervention Name(s)
    Desflurane
    Other Intervention Name(s)
    PROPOFOL
    Intervention Description
    Desflurane vs TIVA, bariatric surgery. Postoperative nausea and pain
    Primary Outcome Measure Information:
    Title
    Awakening time after surgery
    Description
    time noted from anaesthesia stoped to patients awake
    Time Frame
    2 hours postdose
    Title
    Degree of nausea and vomiting after surgery
    Description
    Noted using NRS scale (from 0-10)
    Time Frame
    48 hours postsurgery
    Title
    Degree of pain after surgery
    Description
    Noted using NRS scale (from 0-10)
    Time Frame
    48 hours post surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    TIVA Versus Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery

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