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

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ClinicalTrials.gov Identifier: NCT02666014
Recruitment Status : Recruiting
First Posted : January 28, 2016
Last Update Posted : August 31, 2016
Sponsor:
Collaborator:
Singhealth Foundation
Information provided by (Responsible Party):
Deepak Mathur, KK Women's and Children's Hospital

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.


Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Neuromuscular reversal by Sugammadex Drug: Neuromuscular reversal by Neostigmine Drug: Atropine sulfate-diphenoxylate hydrochloride combination Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Comparison of Sugammadex Versus Neostigmine in Women at High Risk of Postoperative Nausea and Vomiting After Laparoscopic Gynaecological Surgery: A Randomized Controlled Trial
Study Start Date : June 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sugammadex group

The drug is to be diluted with normal saline to make up to 5 ml volume to maintain blinding.

Sugammadex 2 mg/Kg, to be given as a single dose via intravenous injection upon completion of surgery and guided by peripheral nerve stimulation.

Drug: Neuromuscular reversal by Sugammadex
Reversal of neuromuscular blockade
Other Name: Bridion

Active Comparator: Neostigmine group

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.

To be given 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.

Drug: Neuromuscular reversal by Neostigmine
Reversal of neuromuscular blockade

Drug: Atropine sulfate-diphenoxylate hydrochloride combination
As an adjuvant drug to balance muscarinic side effects of Neostigmine, when Neostigmine is administered.




Primary Outcome Measures :
  1. Incidence of self-reported, postoperative nausea and vomiting (PONV) at 6-hours after neuromuscular blockade reversal with sugammadex or neostigmine, in women at high-risk of PONV, after undergoing laparoscopic gynaecological surgery. [ Time Frame: 6 hours after surgery ]

Secondary Outcome Measures :
  1. Incidence of self-reported PONV following administration of Sugammadex or Neostigmine reversal for neuromuscular blockade 24-hours following laparoscopic gynaecological surgery in women at high-risk of PONV. [ Time Frame: 24 hours after surgery ]
  2. Severity of self-reported PONV after administration of Sugammadex or Neostigmine for neuromuscular blockade reversal at 6-hours and 24-hours after undergoing laparoscopic gynaecological surgery in women at high-risk of PONV. [ Time Frame: 6 and 24 hours after surgery ]
  3. Time-interval from the administration of either Sugammadex or Neostigmine to the administration of the first antiemetic dose in women at high-risk of PONV following laparoscopic gynaecological surgery. [ Time Frame: up to 24 hours after surgery ]
  4. Pain intensity after administration of Sugammadex or Neostigmine for neuromuscular blockade reversal in women at high-risk for PONV at 6-hours and 24-hours following laparoscopic gynaecological surgery. [ Time Frame: 6 hours and 24 hours after surgery ]
  5. Quality of recovery score after administration of Sugammadex or Neostigmine for neuromuscular blockade reversal in women at high-risk of PONV at 24 hours following laparoscopic gynaecological surgery. [ Time Frame: 24 hours after surgery ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666014


Contacts
Contact: Jing Wen Ng +65 94590407 Ng.Jing.Wen@kkh.com.sg

Locations
Singapore
KK Women's and Children's Hospital Recruiting
Singapore, Singapore, 229899
Contact: Jing Wen Ng    +65 94590407    Ng.Jing.Wen@kkh.com.sg   
Principal Investigator: Deepak Mathur         
Sub-Investigator: Ban Leong Sng         
Sponsors and Collaborators
KK Women's and Children's Hospital
Singhealth Foundation
Investigators
Study Chair: Alex Sia CMB, KK Hospital

Publications:

Responsible Party: Deepak Mathur, Consultant Anaesthetist, KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT02666014     History of Changes
Other Study ID Numbers: SHF/FG581S/2013
SHF/FG581S/2013 ( Other Grant/Funding Number: SingHealth Foundation Grant )
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Deepak Mathur, KK Women's and Children's Hospital:
PONV
nausea
vomiting
sugammadex
neostigmine

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Atropine
Neostigmine
Diphenoxylate
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinesterase Inhibitors
Enzyme Inhibitors
Parasympathomimetics
Analgesics, Opioid
Narcotics