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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03727607
Other study ID # 2016/1659
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 30, 2016
Est. completion date March 14, 2018

Study information

Verified date October 2018
Source Ostfold Hospital Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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].


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date March 14, 2018
Est. primary completion date December 11, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Desflurane
Desflurane vs TIVA, bariatric surgery. Postoperative nausea and pain

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ostfold Hospital Trust

Outcome

Type Measure Description Time frame Safety issue
Primary Awakening time after surgery time noted from anaesthesia stoped to patients awake 2 hours postdose
Primary Degree of nausea and vomiting after surgery Noted using NRS scale (from 0-10) 48 hours postsurgery
Primary Degree of pain after surgery Noted using NRS scale (from 0-10) 48 hours post surgery
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