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

NCT02666014 | Completed Phase 3 DMC

• 1 other identifier: SHF/FG581S/2013
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Nausea and Vomiting

Keywords

PONV; nausea; vomiting; sugammadex; neostigmine

Outcome Measures

Primary Outcomes (1)

• Incidence of self-reported, postoperative nausea at 24-hours

  Incidence of self-reported, postoperative nausea at 24-hours after neuromuscular blockade reversal with sugammadex or neostigmine, in women at high-risk of PONV, after undergoing laparoscopic gynaecological surgery.

  24 hours after surgery

Secondary Outcomes (5)

• Incidence of self-reported PONV following administration of Sugammadex or Neostigmine reversal for neuromuscular blockade at 6-hours

  6 hours after surgery

• Severity of self-reported PONV after administration of Sugammadex or Neostigmine for neuromuscular blockade reversal at 6-hours and 24-hours

  6 and 24 hours after surgery

• total number of patients with PONV following laparoscopic gynaecological surgery.

  up to 24 hours after surgery

• Pain intensity after administration of Sugammadex or Neostigmine for neuromuscular blockade reversal in women at high-risk for PONV at 6- and 24-hours

  6 hours and 24 hours after surgery

• Quality of recovery score after administration of Sugammadex or Neostigmine for neuromuscular blockade reversal in women at high-risk of PONV at 24 hours

  24 hours after surgery

Study Arms (2)

Sugammadex group

ACTIVE COMPARATOR

Sugammadex 2 mg/Kg will be administrated as a single dose via intravenous injection upon completion of surgery and guided by peripheral nerve stimulation. The drug is to be diluted with normal saline to make up to 5 ml volume to maintain blinding.

Drug: Sugammadex

Neostigmine group

ACTIVE COMPARATOR

Neostigmine 0.040 mg/Kg, along with Atropine 0.015 mg/kg, diluted in normal saline to make up 5 ml total volume to maintain blinding. Neostigmine 0.040 mg/Kg, along with Atropine 0.015 mg/kg will be administrated as a single dose via intravenous injection upon completion of surgery and guided by peripheral nerve stimulation for reversal of neuromuscular blockade produced during surgery. Atropine sulfate-diphenoxylate hydrochloride combination will be an adjuvant drug to balance muscarinic side effects of Neostigmine, when Neostigmine is administered.

Drug: Neostigmine

Interventions

Sugammadex DRUG

Reversal of neuromuscular blockade

Also known as: Bridion

Sugammadex group

Neostigmine DRUG

Reversal of neuromuscular blockade

Neostigmine group

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females
• In-patients
• Age ≥ 21 years
• ASA class 1 or 2
• Undergoing elective laparoscopic, abdominal, gynaecological surgery.
• Weight ≥ 40 Kg or ≤ 100 Kg
• At least 3 risk factors for nausea and vomiting
• Able to give valid, informed consent
• Duration of surgery expected to be 120 minutes or more.

You may not qualify if:

• Less than 3 risk factors for PONV
• Nausea and/or vomiting in the last 72-hours prior to surgery
• Regular antiemetic or opioid use
• Obesity, with body weight ≥ 100.1 Kg
• History of drug or alcohol abuse
• ASA III or worse
• Laparoscopic surgery that is converted to open surgery
• Age ≤ 20-years of age
• Patients with unknown pregnancy status in pre-menopausal women or those currently pregnant or breast-feeding.
• Smokers
• Anaphylaxis or hypersensitivity to study drug(s)
• Day surgery procedure, unsuitable for follow up at 6 and 24-hours postoperatively.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Singhealth Foundation: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (8)

• Abrishami A, Ho J, Wong J, Yin L, Chung F. Sugammadex, a selective reversal medication for preventing postoperative residual neuromuscular blockade. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD007362. doi: 10.1002/14651858.CD007362.pub2.

  PMID: 19821409 BACKGROUND

• Lovstad RZ, Thagaard KS, Berner NS, Raeder JC. Neostigmine 50 microg kg(-1) with glycopyrrolate increases postoperative nausea in women after laparoscopic gynaecological surgery. Acta Anaesthesiol Scand. 2001 Apr;45(4):495-500. doi: 10.1034/j.1399-6576.2001.045004495.x.

  PMID: 11300390 BACKGROUND

• Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.

  PMID: 10485781 BACKGROUND

• Cohen MM, Duncan PG, DeBoer DP, Tweed WA. The postoperative interview: assessing risk factors for nausea and vomiting. Anesth Analg. 1994 Jan;78(1):7-16. doi: 10.1213/00000539-199401000-00004.

  PMID: 8267183 BACKGROUND

• Dahl V, Pendeville PE, Hollmann MW, Heier T, Abels EA, Blobner M. Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery. Eur J Anaesthesiol. 2009 Oct;26(10):874-84. doi: 10.1097/EJA.0b013e32832c605b.

  PMID: 19455040 BACKGROUND

• Miller RD. Sugammadex: an opportunity to change the practice of anesthesiology? Anesth Analg. 2007 Mar;104(3):477-8. doi: 10.1213/01.ane.0000255645.64583.e8. No abstract available.

  PMID: 17312188 BACKGROUND

• Naguib M. Sugammadex: another milestone in clinical neuromuscular pharmacology. Anesth Analg. 2007 Mar;104(3):575-81. doi: 10.1213/01.ane.0000244594.63318.fc.

  PMID: 17312211 BACKGROUND

• Yang LP, Keam SJ. Sugammadex: a review of its use in anaesthetic practice. Drugs. 2009;69(7):919-42. doi: 10.2165/00003495-200969070-00008.

  PMID: 19441874 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Alex Sia

  CMB, KK Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: January 28, 2016
• Study Start: June 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 28, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)