Trial Outcomes & Findings for Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery (NCT NCT01449708)

NCT ID: NCT01449708

Last Updated: 2016-03-21

Results Overview

Postoperative Nausea and Vomiting

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 124 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2016-03-21

Participant Flow

Participant milestones

Measure	Classic/Balanced Anesthesia Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. (Control) postop management in both groups is similar in both groups	TIVA TIVA NoNarc (Study): - patients in both groups receive antiemetic prophylaxis \- patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
Overall Study STARTED	61	63
Overall Study COMPLETED	59	60
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Classic/Balanced Anesthesia Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. (Control) postop management in both groups is similar in both groups	TIVA TIVA NoNarc (Study): - patients in both groups receive antiemetic prophylaxis \- patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
Overall Study Protocol Violation	0	1
Overall Study surgical complication	1	2
Overall Study respiratory failure	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Classic/Balanced Anesthesia n=59 Participants Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. * patients in both groups receive antiemetic prophylaxis * postop management in both groups is similar in both groups	TIVA n=60 Participants * 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	Total n=119 Participants Total of all reporting groups
Age, Continuous	50.4 years STANDARD_DEVIATION 3.2 • n=93 Participants	50.5 years STANDARD_DEVIATION 3.5 • n=4 Participants	50.4 years STANDARD_DEVIATION 2.4 • n=27 Participants
Sex: Female, Male Female	43 Participants n=93 Participants	39 Participants n=4 Participants	82 Participants n=27 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	21 Participants n=4 Participants	37 Participants n=27 Participants
Region of Enrollment United States	59 participants n=93 Participants	60 participants n=4 Participants	119 participants n=27 Participants

PRIMARY outcome

Timeframe: 24 hours

Postoperative Nausea and Vomiting

Outcome measures

Measure	Classic / Balanced Anesthesia n=59 Participants Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control)	TIVA n=60 Participants patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
PONV During the First 24 Hours After Bariatric Surgery	22 participants	12 participants

SECONDARY outcome

Timeframe: 24hours

Outcome measures

Measure	Classic / Balanced Anesthesia n=59 Participants Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control)	TIVA n=60 Participants patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
Number of Patients Requiring Antiemetic Rescue Medication (AERM)	26 participants	17 participants

SECONDARY outcome

Timeframe: 24 hours

Population: analysis was conducted with all participants and NOT per arm

Outcome measures

Measure	Classic / Balanced Anesthesia n=119 Participants Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control)	TIVA patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
PONV Between Different Surgical Procedures (Percentage of Participants) revision LRYGB	23.1 percentage of participants	—
PONV Between Different Surgical Procedures (Percentage of Participants) Sleeve Gastrectomy	58.6 percentage of participants	—
PONV Between Different Surgical Procedures (Percentage of Participants) Gastric Bypass (LRYGB)	19.4 percentage of participants	—
PONV Between Different Surgical Procedures (Percentage of Participants) Gastric Band	0 percentage of participants	—
PONV Between Different Surgical Procedures (Percentage of Participants) Conversion to LRYGB	0 percentage of participants	—

Adverse Events

Classic/Balanced Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TIVA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Patrick Ziemann-Gimmel, MD

Coastal Anesthesiology

Phone: 904-819-4478

Email: pziemann@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place