TIVA Versus Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery

NCT03727607 | Completed Phase 2

• 1 other identifier: 2016/1659
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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 \[18\].

Conditions

Total Intravenous Anesthesia; Desflurane; Obesity; Pain, Postoperative; Nausea, Postoperative

Outcome Measures

Primary Outcomes (3)

• Awakening time after surgery

  time noted from anaesthesia stoped to patients awake

  2 hours postdose

• Degree of nausea and vomiting after surgery

  Noted using NRS scale (from 0-10)

  48 hours postsurgery

• Degree of pain after surgery

  Noted using NRS scale (from 0-10)

  48 hours post surgery

Study Arms (2)

Gass

ACTIVE COMPARATOR

DESFLURANE ANESTHESIA

Drug: Desflurane

TIVA

ACTIVE COMPARATOR

TOTAL INTRAVENOUS ANESTHESIA

Drug: Desflurane

Interventions

Desflurane DRUG

Desflurane vs TIVA, bariatric surgery. Postoperative nausea and pain

Also known as: PROPOFOL

Gass; TIVA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ostfold Hospital Trust: lead

MeSH Terms

Conditions

Obesity; Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Desflurane; Propofol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized control trial.

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: November 1, 2018
• Study Start: January 30, 2016
• Primary Completion: December 11, 2017
• Study Completion: March 14, 2018
• Last Updated: November 1, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share