NCT07464288

Brief Summary

This randomized controlled study aims to evaluate the effects of deep versus moderate neuromuscular blockade on intraoperative driving pressure and the development of postoperative critical respiratory events in patients undergoing abdominal surgery under general anesthesia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

March 6, 2026

Last Update Submit

March 15, 2026

Conditions

Driving PressureNeuromuscular Blockade MonitoringPostoperative Respiratory Complications

Outcome Measures

Primary Outcomes (1)

  • Mean Intraoperative Driving Pressure

    Driving pressure will be calculated as plateau pressure minus positive end-expiratory pressure (PEEP) during volume-controlled ventilation. Measurements will be recorded at 30-minute intervals throughout surgery, and the mean value per patient will be calculated.

    From immediately after intubation until the end of surgery (intraoperative period)

Secondary Outcomes (1)

  • Incidende of Postoperative Critical Respiratory Events

    From immediately after extubation and until 30 minutes after arrival to PACU

Study Arms (2)

Arm 1: Deep Neuromuscular Block

EXPERIMENTAL

Deep Neuromuscular Block: Rocuronium titrated according to quantitative neuromuscular monitoring \[Post-Tetanic count (PTC): ≥1; Train of Four (TOF) Count: 0\]

Drug: Rocuronium

Arm 2: Moderate Neuromuscular Block

ACTIVE COMPARATOR

Moderate Neuromuscular Block: Rocuronium titrated according to quantitative neuromuscular monitoring \[Train of Four (TOF) Count: 1-3\]

Drug: Rocuronium

Interventions

RocuroniumDRUG

Rocuronium will be administered intravenously as bolus and continuous infusion to achieve target neuromuscular blockade depth according to group allocation. Neuromuscular function will be monitored using quantitative TOF monitoring.

Arm 1: Deep Neuromuscular BlockArm 2: Moderate Neuromuscular Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective abdominal surgery under general anesthesia that is expected to last longer than one hour
  • ASA I-II-III
  • Age ≥18 years
  • Written informed consent

You may not qualify if:

  • Refusal to participate in the study
  • ASA ≥ IV
  • Age \<18
  • Obesity (BMI\>30) and cachexia (BMI \<18)
  • Laparoscopic surgery
  • Emergency procedure
  • Allergy to drugs used during induction and maintenance of general anesthesia
  • Presence of psychiatric/neurologic/neuromuscular disease
  • Risk of malignant hyperthermia or having any relative with history of malignant hyperthermia
  • Use of medications that may affect neuromuscular function (anticonvulsants, aminoglycosides, magnesium salts, etc.)
  • Pregnancy
  • Presence of advanced chronic lung disease (asthma, COPD, etc.)
  • Presence of advanced liver and renal disease (creatinine\>1.6, liver function tests above twice the normal range)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06530, Turkey (Türkiye)

Location

Related Publications (7)

  • Zhang YW, Li Y, Huang WB, Wang J, Qian XE, Yang Y, Huang CS. Utilization of deep neuromuscular blockade combined with reduced abdominal pressure in laparoscopic radical gastrectomy for gastric cancer: An academic perspective. World J Gastrointest Surg. 2023 Jul 27;15(7):1405-1415. doi: 10.4240/wjgs.v15.i7.1405.

    PMID: 37555115BACKGROUND

  • Thilen SR, Weigel WA, Todd MM, Dutton RP, Lien CA, Grant SA, Szokol JW, Eriksson LI, Yaster M, Grant MD, Agarkar M, Marbella AM, Blanck JF, Domino KB. 2023 American Society of Anesthesiologists Practice Guidelines for Monitoring and Antagonism of Neuromuscular Blockade: A Report by the American Society of Anesthesiologists Task Force on Neuromuscular Blockade. Anesthesiology. 2023 Jan 1;138(1):13-41. doi: 10.1097/ALN.0000000000004379.

    PMID: 36520073BACKGROUND

  • Rezaiguia-Delclaux S, Laverdure F, Genty T, Imbert A, Pilorge C, Amaru P, Sarfati C, Stephan F. Neuromuscular Blockade Monitoring in Acute Respiratory Distress Syndrome: Randomized Controlled Trial of Clinical Assessment Alone or With Peripheral Nerve Stimulation. Anesth Analg. 2021 Apr 1;132(4):1051-1059. doi: 10.1213/ANE.0000000000005174.

    PMID: 33002927BACKGROUND

  • Chaves-Cardona H,Hernandez-Torres V,Kiley S,Renew J

    BACKGROUND

  • Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.

    PMID: 26947624BACKGROUND

  • Tonetti T,Vasques F,Rapetti F,Maiolo G,Collino F,Romitti F,Camporota L,Cressoni M,Cadringher P,Quintel M,Gattinoni L

    BACKGROUND

  • Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.

    PMID: 25693014BACKGROUND

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Kubilay G YILMAZ

CONTACT

+90 537 274 16 72kgyilmaz91@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 11, 2026

Study Start

March 23, 2026

Primary Completion

April 23, 2026

Study Completion

April 24, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)