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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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 blockadeDrug: Atropine sulfate-diphenoxylate hydrochloride combination
As an adjuvant drug to balance muscarinic side effects of Neostigmine, when Neostigmine is administered.
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
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
|Contact: Jing Wen Ng||+65 94590407||Ng.Jing.Wen@kkh.com.sg|
|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|
|Study Chair:||Alex Sia||CMB, KK Hospital|