Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions.

NCT03170661 | Completed Phase 4 Results DMC

• 1 other identifier: p17.049
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

A deep neuromuscular block (NMB) is often associated with improved surgical conditions especially in laparoscopic surgery. We previously showed that deep NMB is superior to a moderate NMB under propofol anesthesia. However, this may not apply to sevoflurane anesthesia and sevoflurane by itself produces some degree of muscle relaxation. We therefore plan to investigate the effect of deep NMB on surgical conditions under sevoflurane anesthesia maintenance.

Conditions

Surgical Conditions

Outcome Measures

Primary Outcomes (1)

• Leiden Surgical Rating Scale

  During the on average 3 hour procedure, the surgical condition will be scored by the surgeon using a 5-point surgical rating scale at 15 minute intervals(1: poor ; 5: optimal) Mean and standard deviation of the average of all leiden surgical rating scale will be reported.

  during surgery

Secondary Outcomes (5)

• Postoperative Measurements and Outcomes; Pain Scores

  During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals

• Intraoperative Hemodynamic Conditions

  Perioperative measurements at 15 minute interval (on average during 3 hours)

• Postoperative Measurements and Outcomes; Sedation Levels

  During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals

• Postoperative Measurements and Outcomes; Saturation

  During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals

• Intraoperative Nociception Level

  Perioperative measurements at 15 minute interval (on average during 3 hours)

Study Arms (2)

Moderate neuromuscular block

NO INTERVENTION

Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four

Deep neuromuscular block

EXPERIMENTAL

Subjects will receive deep neuromuscular block, aimed at 1-2 twitches post tetanic count

Drug: Deep neuromuscular block

Interventions

Deep neuromuscular block DRUG

Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count

Also known as: high dose rocuronium

Deep neuromuscular block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with renal or prostatic disease who are will undergo an elective laparoscopic renal surgical procedure or laparoscopic prostatectomy;
• American Society of Anesthesiologists (ASA) class I-III
• \> 18 years of age;
• Ability to give oral and written informed consent.

You may not qualify if:

• Known or suspected neuromuscular disorders impairing neuromuscular function;
• Allergies to muscle relaxants, anesthetics or narcotics;
• A (family) history of malignant hyperthermia;
• Women who are or may be pregnant or are currently breast feeding;
• Renal insufficiency, as defined by glomerular filtration rate \< 30 ml/h creatinine.
• Previous retroperitoneal surgery at the site of the current surgery.
• Body mass index \> 35 kg/m2

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, Netherlands

Location

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Drs. Maarten Honing
• Organization: LUMC

g.h.m.honing@lumc.nl

0715264038

Study Officials

• Albert Dahan, MD PhD

  LUMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 31, 2017
• Study Start: June 14, 2017
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: May 13, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-04

Locations

NL (1)