Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-10-31

Brief Summary

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Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after surgery and general anesthesia. The results of our observational study indicate that 42.7% of patients require medication to treat PONV in the first 24 hours after bariatric surgery despite our aggressive perioperative approach with triple prophylaxis. Common risk factors for PONV are the use of intraoperative narcotics and anesthetic gases.

Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a reduction of narcotic consumption, desaturations and use of antiemetic medication.

Our study hypothesis is that different types of anesthetics reduce PONV further.

Patient would be randomly assigned to receive either our current intraoperative management or a narcotic free, total intravenous general anesthetic (TIVA).

The investigators hope to improve patients' satisfaction by reducing PONV in the postoperative period.

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Detailed Description

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Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Balanced Anesthesia

Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

NoNarc TIVA

Patients will receive narcotic free total intravenous anesthesia with Propofol, dexmedetomidine and ketamine

Group Type ACTIVE_COMPARATOR

TIVA NoNarc

Intervention Type DRUG

* patients in both groups receive antiemetic prophylaxis
* patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
* postop management in both groups is similar in both groups

Interventions

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TIVA NoNarc

* patients in both groups receive antiemetic prophylaxis
* patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
* postop management in both groups is similar in both groups

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients scheduled for bariatric surgery at Flagler Hospital will be included after written and informed consent.

Exclusion Criteria

* Patients will be excluded from the study if they don't consent to participate in the study. Patients allergic to any of the study medication will be excluded. Patients with second or third degree heart block will be excluded.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No