Deep Neuromuscular Relaxation Optimizing Low-Pressure Bariatric Surgery
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|ClinicalTrials.gov Identifier: NCT03803982|
Recruitment Status : Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : January 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bariatric Surgery||Procedure: Deep Neuromuscular Blockade Drug: Sugammadex||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The investigators propose to conduct a double-blind RCT comparing deep neuromuscular blockade to standard blockade during bariatric surgery. Participants will be randomized to one of the two groups in a 1:1 ratio.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The patients, surgeons, ward and PACU nurses, research assistants, and surgical house-staff will be blinded to the randomization. The anesthesiologist will be aware of the randomization as this will directly impact the anesthetic delivered to the patients.|
|Official Title:||Deep Neuromuscular Relaxation Optimizing Low-Pressure Bariatric Surgery: A Randomized Controlled Trial|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: Deep Neuromuscular Blockade, Sugammadex
All patients will receive anesthetic induction and maintenance as per routine using a combination of propofol, opioids, dexamethasone, and 0.6 mg/kg of rocuronium for induction. Patients will also receive lidocaine 1 mg/kg/hour IV infusion, followed by 3-5 mg of morphine equivalents prior to extubation. Patient monitoring will be according to local practice and consist of electrocardiography, blood pressure, heart rate and bispectral index monitoring. Neuromuscular function will be monitored every 20 minutes using a standardized nerve monitor. After induction and intubation, patients in the Deep Neuromuscular Blockade group (experimental group) will receive additional rocuronium to achieve a NMB blockade of TOF of 0 twitch and maintained at this level until reversal.
Procedure: Deep Neuromuscular Blockade
The proposed intervention in this study is delivery of an anesthetic with Deep Neuromuscular Blockage (NMB), which will be defined as a TOF of 0 and 2-3 twitches in the post-tetanic count.
Sugammadex will be used to reverse the deep neuromuscular blockade in the experimental group.
No Intervention: Standard Anesthetic
Patients in the standard anesthetic (or control group) will also receive anesthetic induction as per routine using a combination of propofol, opioids, dexamethasone, and rocuronium, with a lidocaine infusion. Patient monitoring will be similar to the experimental group, with electrocardiography, blood pressure, heart rate, and bispectral index monitoring. Patients in the control group will receive rocuronium 30 mg intravenous prior to intubation, followed by repeated 10 mg doses to reach a TOF of 1-2 twitches.
- Maximum IAP [ Time Frame: Intraoperatively ]Maximum Intra-Abdominal Pressure, as assessed by the degree of pneumoperitoneum for each position (supine and reverse Trendelenburg)
- Leiden-Surgical Rating Scale [ Time Frame: Intraoperatively ]Assessment of operating conditions, as assessed by the surgeon, assessed at the beginning of each position change (supine and reverse Trendelenburg). Scale ranges from 1 (extremely poor operating conditions) to 5 (optimal conditions).
- Postoperative Pain [ Time Frame: Post Operative Day 1 ]Postoperative pain as reported by the patient. Pain will be assessed on post operative day 1 at 8 am, noon, and 8pm, and an average pain score will then be calculated for post operative day 1. Pain will be assessed on an 11-point scale ranging from 0 (no pain) to 10 (most pain imaginable)
- Operative Time [ Time Frame: Intraoperative ]Two operative times will be recorded. The first will be related strictly to the surgery, from time of Veress needle insertion to time of removal of the final port. In addition, total operative time will also be recorded which will include time of induction and reversal of anesthesia
- Postoperative Nausea [ Time Frame: Postoperative nausea scores will be recorded at 8 am, 2 pm, and 8pm on post operative day 1. Nausea will be measured on an 11-point scale ranging from 0 (no nausea) to 10 (most nausea imaginable). ]Postoperative nausea as reported by the patient
- Postoperative Narcotic Use [ Time Frame: During index admission, up to one week. ]Amount of narcotic used by the patient postoperative
- Length of Stay [ Time Frame: During index admission; through study completion, an average of 5 days ]Length of stay
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): NCT03803982
|Contact: Dennis Hong, MD, MSc||905-522-1155 ext firstname.lastname@example.org|
|Principal Investigator:||Dennis Hong, MD, MSc||Centre for Minimal Access Surgery|