Deep Neuromuscular Relaxation Optimizing Low-Pressure Bariatric Surgery

Bariatric Surgery Clinical Trial

Official title:

Deep Neuromuscular Relaxation Optimizing Low-Pressure Bariatric Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03803982
• Other study ID #: low pressure pneumoperitoneum
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2019
• Est. completion date: December 2020

Study information

• Verified date: January 2019
• Source: McMaster University
• Contact: Dennis Hong, MD, MSc
• Phone: 905-522-1155
• Email: dennishong70[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the use of deep neuromuscular blockade and low-pressure pneumoperitoneum in bariatric surgery. The investigators propose to conduct a double-blind randomized controlled trial (RCT) comparing deep neuromuscular blockade versus standard blockade, and its impact on operative conditions during bariatric surgery. This trial will be conducted at one of the highest volume bariatric centers in Canada. This study also aims to examine the effects of deep neuromuscular blockade on patient-relevant outcomes, including postoperative pain and narcotic use. The investigators anticipate this study will facilitate the continual improvement of care provided to a growing number of bariatric patients.

Description:

This will be a double-blind randomized controlled trial comparing patients undergoing a deep neuromuscular blockade with a paralytic reversal agent versus patients undergoing standard anesthetic protocols in low-pressure pneumoperitoneum bariatric surgery. The study population will include patients aged 18-65 referred to St. Joseph's Healthcare for Roux-en-Y Gastric Bypass (RYGB) after completion of standard work-up for bariatric surgery through the Ontario Bariatric Network (OBN). The investigators plan to recruit and randomize 100 patients in a 1:1 ratio between deep NMB and standard anesthetic in low-pressure pneumoperitoneum bariatric surgery. Once enrolled in the study, patients will be assigned to one of the two groups using computer-based randomization on REDCap software. Allocation will be concealed until the time of the operation and will be provided directly to the anesthetist in opaque envelopes. The anesthetist will be aware of the assigned group, but the patient, surgeon, PACU nurses, ward nurses, research assistants and house staff will be blinded. The primary outcomes to be examined will include maximum intra-abdominal pressure, Leiden-Surgical Rating Scale, and postoperative pain scores. Secondary outcomes will include operative time, postoperative nausea, postoperative narcotic use, and length of stay.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• The patient meets NIH criteria for bariatric surgery and has not received a previous bariatric surgical procedure

• The patient is aged 18-65 years and has completed the screening and preparation process prescribed by the Ontario Bariatric Network

Exclusion Criteria:

• Inability to give informed consent

• ASA > 4

• Planned procedure other than RYGB or contraindications to RYGB

• BMI > 55 kg/m2

• Revisional procedure

• Allergies or suspected allergies to anesthetic medications (rocuronium or sugammadex)

• Renal insufficiency (GFR < 30ml/min)

• Family or personal history of malignant hyperthermia or personal history of neuromuscular disease

• History of chronic pain needing daily medications for the last >3 months

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

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.

Drug:
• Sugammadex
Sugammadex will be used to reverse the deep neuromuscular blockade in the experimental group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum IAP	Maximum Intra-Abdominal Pressure, as assessed by the degree of pneumoperitoneum for each position (supine and reverse Trendelenburg)	Intraoperatively
Primary	Leiden-Surgical Rating Scale	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).	Intraoperatively
Primary	Postoperative Pain	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)	Post Operative Day 1
Secondary	Operative Time	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	Intraoperative
Secondary	Postoperative Nausea	Postoperative nausea as reported by the patient	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).
Secondary	Postoperative Narcotic Use	Amount of narcotic used by the patient postoperative	During index admission, up to one week.
Secondary	Length of Stay	Length of stay	During index admission; through study completion, an average of 5 days