Comparison of the Effects of Neostigmine With Sugammadex on Postoperative Nausea and Vomiting.

Incidence of Postoperative Nausea and Vomiting Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02286752
• Other study ID #: Odu-6
• Status: Completed
• Phase: Phase 4
• First received: November 3, 2014
• Last updated: January 11, 2015
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: T.C. ORDU ÜNIVERSITESI
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Postoperative nausea and vomiting is one of most common complications after general anesthesia. Female sex, history of postoperative nausea and vomiting, motion sickness, non smoker status, opioid administration are known as risk factors for developing postoperative nausea and vomiting.

It has been suggest that antagonism of residual neuromuscular block with a mixture of neostigmine and atropine at the end of the surgery increases the risk of postoperative nausea and vomiting.

Sugammadex is a very safe drug with almost no serious adverse effects. The known adverse effects include slight coughing, movement, an altered taste sensation in the mouth, transient prolongation of the QT interval, hypersensitivity, and a short term prolongation of the activated partial thromboplastin time.

The aim of this study was to compare the sugammadex versus neostigmine plus atropine for reversal of rocuronium induced neuromuscular blockade in terms of incidence of postoperative nausea and vomiting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status 1 and 2

• endotracheal intubation and general anesthesia scheduled for elective surgery

Exclusion Criteria:

• age < 18 years, > 65 years

• pregnancy

• refusal to participate and patients already participating in another study

• allergy to study drugs

• communication difficulty

• psychiatric and neurological disorders

• use of analgesics or sedative or antiemetic drugs within 24 hours before surgery.

• emergency surgery

• history of drug or alcohol abuse

• ASA 3 and above

• patients with vertigo

• Laparoscopic surgery, oncologic surgery, strabismus and mid ear surgery neurosurgery, gynecologic surgery, breast surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Incidence of Postoperative Nausea and Vomiting
• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Neostigmine
for reversal of neuromuscular block: 0,05 mg kg-1 neostigmine + 0,025 mg kg-1 atropine
• sugammadex
for reversal of neuromuscular block: sugammadex 2 mg kg-1

Locations

Country	Name	City	State
Turkey	Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital	Altinordu	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verbal Descriptive Scale	0: no nausea 1: mild 2: moderate 3: severe	within postoperative 24 hours	No