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

NCT ID: NCT02286752

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-01-31

Brief 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.

Conditions

Incidence of Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

neostigmine

Group Type: ACTIVE_COMPARATOR

Neostigmine

Intervention Type: DRUG

for reversal of neuromuscular block: 0,05 mg kg-1 neostigmine + 0,025 mg kg-1 atropine

sugammadex

Group Type: ACTIVE_COMPARATOR

sugammadex

Intervention Type: DRUG

for reversal of neuromuscular block: sugammadex 2 mg kg-1

Interventions

Neostigmine

for reversal of neuromuscular block: 0,05 mg kg-1 neostigmine + 0,025 mg kg-1 atropine

Intervention Type: DRUG

sugammadex

for reversal of neuromuscular block: sugammadex 2 mg kg-1

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ordu University

OTHER

Sponsor Role: lead

Responsible Party

özgür yağan

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital

Altinordu, Ordu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Odu-6

Identifier Type: -

Identifier Source: org_study_id