Title

Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery
Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting (PONV) in Bariatric Surgery
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Study Participants

    124
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.
See above
Study Started
Nov 30
2011
Primary Completion
Oct 31
2012
Study Completion
Oct 31
2012
Results Posted
Mar 21
2016
Estimate
Last Update
Mar 21
2016
Estimate

Drug 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

Balanced Anesthesia No Intervention

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

NoNarc TIVA Active Comparator

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

Criteria

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.

Summary

Classic/Balanced Anesthesia

TIVA

All Events

Event Type Organ System Event Term

PONV During the First 24 Hours After Bariatric Surgery

Postoperative Nausea and Vomiting

Classic / Balanced Anesthesia

22.0
participants

TIVA

12.0
participants

Number of Patients Requiring Antiemetic Rescue Medication (AERM)

Classic/Balanced Anesthesia

26.0
participants

TIVA

17.0
participants

PONV Between Different Surgical Procedures (Percentage of Participants)

All Study Participants

Conversion to LRYGB

Gastric Band

Gastric Bypass (LRYGB)

19.4
percentage of participants

revision LRYGB

23.1
percentage of participants

Sleeve Gastrectomy

58.6
percentage of participants

Total

119
Participants

Age, Continuous

50.4
years (Mean)
Standard Deviation: 2.4

Region of Enrollment

Sex: Female, Male

Overall Study

Classic/Balanced Anesthesia

TIVA

Drop/Withdrawal Reasons

Classic/Balanced Anesthesia

TIVA