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

NCT02286752 | Completed Phase 4

• 1 other identifier: Odu-6
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Verbal Descriptive Scale

  0: no nausea 1: mild 2: moderate 3: severe

  within postoperative 24 hours

Study Arms (2)

neostigmine

ACTIVE COMPARATOR

Drug: Neostigmine

sugammadex

ACTIVE COMPARATOR

Drug: sugammadex

Interventions

Neostigmine DRUG

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

neostigmine

sugammadex DRUG

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

sugammadex

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status 1 and 2
• endotracheal intubation and general anesthesia scheduled for elective surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital

Altinordu, Ordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vomiting

Interventions

Neostigmine; Sugammadex

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 10, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 13, 2015

Record last verified: 2015-01

Locations

TU (1)