Obesity Clinical Trial
Official title:
A Randomized Controlled Trial - Total Intravenous Anaesthesia Versus Inhaled Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery. Postoperative Pain and Nausea
Verified date | October 2018 |
Source | Ostfold Hospital Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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].
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ostfold Hospital Trust |
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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