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Completed

NCT Number: NCT02286752

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital

Altinordu, Ordu, 52100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neostigmine

Drug

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

Sugammadex

Drug

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

Primary outcomes

  1. Verbal Descriptive Scale

    Time frame: within postoperative 24 hours

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

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 10, 2014
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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