Sugammadex Versus Neostigmine for Postoperative Nausea and Vomiting After Laparoscopic Gynaecological Surgery

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The laparoscopic technique is commonly employed for abdominal gynaecological surgery in women. Postoperative nausea and vomiting (PONV) may occur in 30% of women undergoing gynaecological surgery. In patients with multiple risk factors for nausea and vomiting, the incidence is up to 80%. PONV has a significant negative effect on patient satisfaction after anesthesia and is one of the most common causes for unexpected hospital admissions in day-surgery.

Sugammadex and Neostigmine are both drugs that are used to reverse the effect of muscle relaxation producing drugs that are commonly used during surgery. Neostigmine has been the drug of common use for this purpose, but PONV is reported with its usage.

With this research we intend to determine whether the trial drug Sugammadex would reduce the incidence of PONV in high-risk women after undergoing laparoscopic gynaecological surgery when compared to Neostigmine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: KK Women's and Children's Hospital
• Collaborator: Singhealth Foundation
• Treatments: Atropine; Diphenoxylate; Neostigmine

Criteria

Inclusion Criteria:

1. Females

2. In-patients

3. Age ≥ 21 years

4. ASA class 1 or 2

5. Undergoing elective laparoscopic, abdominal, gynaecological surgery.

6. Weight ≥ 40 Kg or ≤ 100 Kg

7. At least 3 risk factors for nausea and vomiting

8. Able to give valid, informed consent

9. Duration of surgery expected to be 120 minutes or more.

Exclusion Criteria:

1. Less than 3 risk factors for PONV

2. Nausea and/or vomiting in the last 72-hours prior to surgery

3. Regular antiemetic or opioid use

4. Obesity, with body weight ≥ 100.1 Kg

5. History of drug or alcohol abuse

6. ASA III or worse

7. Laparoscopic surgery that is converted to open surgery

8. Age ≤ 20-years of age

9. Patients with unknown pregnancy status in pre-menopausal women or those currently pregnant or breast-feeding.

10. Smokers

11. Anaphylaxis or hypersensitivity to study drug(s)

12. Day surgery procedure, unsuitable for follow up at 6 and 24-hours postoperatively.