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

NCT01449708 | Completed Phase 4 Results DMC

• 1 other identifier: 3766 - 6886
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

Bariatric Surgery; TIVA; PONV; non-opioid; OSA

Outcome Measures

Primary Outcomes (1)

• PONV During the First 24 Hours After Bariatric Surgery

  Postoperative Nausea and Vomiting

  24 hours

Secondary Outcomes (2)

• Number of Patients Requiring Antiemetic Rescue Medication (AERM)

  24hours

• PONV Between Different Surgical Procedures (Percentage of Participants)

  24 hours

Study Arms (2)

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

Drug: TIVA NoNarc

Interventions

TIVA NoNarc 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

NoNarc TIVA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coastal Anesthesiology Consultants: lead

Study Sites (1)

Flagler Hospital

Saint Augustine, Florida, 32086, United States

Location

Related Publications (1)

• Ziemann-Gimmel P, Goldfarb AA, Koppman J, Marema RT. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. Br J Anaesth. 2014 May;112(5):906-11. doi: 10.1093/bja/aet551. Epub 2014 Feb 18.

  PMID: 24554545 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Results Point of Contact

• Title: Patrick Ziemann-Gimmel, MD
• Organization: Coastal Anesthesiology

pziemann@yahoo.com

904-819-4478

Study Officials

• Patrick Ziemann-Gimmel, MD

  Coastal Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiologist, Principal Investigator

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 10, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 21, 2016
• Results First Posted: March 21, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)