Impact of ERAS on Postoperative Nausea and Vomiting After Sleeve

NCT05996887 | Unknown DMC

• 1 other identifier: 820:6/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The use of bariatric surgery in the treatment of severe obesity has several benefits in terms of sustainable weight loss, improvements, or resolution of several metabolic comorbidities as well as improved life expectancy. Gastric surgery, history of acid reflux and reduction in gastric size, in particular after laparoscopic sleeve gastrectomy (LSG), surgery may further contribute to postoperative nausea and vomiting (PONV). The combination of antiemetic drugs that act at different receptors is more effective than using only one drug in preventing PONV in patients with increased risk for these events.

Conditions

Nausea and Vomiting, Postoperative

Keywords

sleeve gastrectomy; nausea; vomiting

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative nausea and vomiting

  number and percentage of episode of nausea and vomiting : I = no nausea or vomiting, II = nausea but no vomiting, III = mild to moderate vomiting, and IV = severe and frequent vomiting more than five times within 24h. The severity of postoperative nausea (PON) was assessed using a numeric rating scale (I = mild, II = mod¬erate, III = severe).

  36 hours

Secondary Outcomes (5)

• Time to first administration of rescue antiemetic drug.

  36 hours

• postoperative opioid consumption.

  36 hours

• Time to tolerate oral fluid

  36 hours

• The quality of recovery.

  36 hours

• complications.

  36 hours

Study Arms (2)

non- enhanced recovery after surgery

PLACEBO COMPARATOR

All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg and ondansetron 8 mg in addition to standard care protocol.

Other: standard care protcol

enhanced recovery after surgery

ACTIVE COMPARATOR

All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg, and ondansetron 8 mg in addition to following the recommendation of ERAS society guidelines.

Other: enhanced recovery protocol

Interventions

standard care protcol OTHER

All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg and ondansetron 8 mg in addition to standard care protocol.

Also known as: control

non- enhanced recovery after surgery

enhanced recovery protocol OTHER

All patients will receive antiemetics as haloperidol 2 mg and dexamethasone 8 mg and ondansetron 8 mg in addition to following the recommendation of ERAS society guidelines.

Also known as: ERAC

enhanced recovery after surgery

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \* Age: 18-60 years
• Sex: Both sex
• ASA Physical Status: II, III.
• Body mass index: Between 40 and 60 kg/m2.
• Participants: Patients who are undergoing elective Sleeve Gastrectomy

You may not qualify if:

• Patients with hypersensitivity or contraindication to haloperidol, dexamethasone, or ondansetron.
• Serious complications in the perioperative period (such as shock, cardiac arrest, hemorrhage, needing transfusion).
• Psychiatric disorder.
• History of migraine.
• Use of opioid, hormonal, anti-inflammatory, and antiemetic medication 24 h prior to surgery.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University

Minya, Minya Governorate, 61511, Egypt

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Condition Hierarchy (Ancestors)

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

Study Officials

• haidy S mansour, MD

  Assistant professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

haidy s mansour, MD

CONTACT

1221802324; haidy_mourad@yahoo.com

hassan M hetta, MD

CONTACT

1010901114; hassan.hetta@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anesthesia and ICU

Study Record Dates

• First Submitted: July 29, 2023
• First Posted: August 18, 2023
• Study Start: July 30, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)