Effects of Depth of Neuromuscular Blockade and Insufflation Pressure on Surgical Conditions

Randomized, Controlled, Parallel Group, Double Blind Trial to Compare the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures Using a 2x2 Factorial Design in Patients Undergoing Laparoscopic Cholecystectomy (Protocol No. MK-8616-076-00 also known as SCH 900616, P07982) - Effects of Depth of Neuromuscular Blockade and Insufflation Pressure on Surgical Conditions

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001886-33-DE

Enrollment

120

Registered

2012-08-22

Start date

2012-10-30

Completion date

Unknown

Last updated

2014-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing elective in-patient laparoscopic cholecystectomy procedures under general anesthesia with neuromuscular relaxation and active reversal of neuromuscular blockade MedDRA version: 16.1 Level: LLT Classification code 10018061 Term: General anesthesia System Organ Class: 100000004865

Interventions

Trade Name: Bridion Pharmaceutical Form: Solution for injection INN or Proposed INN: Sugammadex CAS Number: 343306-79-6 Current Sponsor code: MK-8616, SCH900616 Other descriptive name: SUGAMMADEX SODI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects must be: Males/Females = 18 yrs; ASA (American Society of Anesthesiologists) Class 1, 2 or 3; scheduled for laparoscopic cholecystectomy (standard 4-hole) procedure under general anesthesia with total intravenous anesthesia (TIVA) using propofol and remifentanil and is expected to undergo rocuronium-induced neuromuscular blockade for endotracheal intubation and require active reversal of neuromuscular blockade. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Subjects with neuromuscular disorders that may affect neuromuscular blockade and/or assessments will be excluded from this study, in addition subjects who cannot meeting general standards for anesthesia trials (inability to intubate, renal/hepatic dysfunction, allergies to general anesthesia medications, malignant hyperthermia, interactions with toremifene/fusidic acid, pregnant patients, previous enrollment in trials or relation to staff) will also be excluded.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the trial is to assess the benefit of deep neuromuscular blockade in surgical conditions when compared to standard neuromuscular blockade in patients undergoing elective in-patient laparoscopic cholecystectomy procedures.;Secondary Objective: The key secondary trial objective is to assess whether the use of low insufflation pressure improves the overall patient's pain score within 24 hours (average of all pain assessments at 1, 2, 4 and 24 h) as compared to standard insufflation pressure, based on a standard pain scale following a laparoscopic cholecystectomy. An additional secondary objective for this study is to evaluate the visual field during laparoscopy (as determined by the surgeon) after use of sustained deep neuromuscular blockade compared to standard neuromuscular blockade. ;Primary end point(s): The Primary Endpoint for the trial is the surgeon's overall satisfaction with the surgical conditions rated at the end of the surgery using a numerical scale with scores from 0 (=poor, needed intervention) to 10 (=excellent). The Primary Efficacy Endpoint is related to the Primary Trial Objective. ;Timepoint(s) of evaluation of this end point: This evaluation will occur within 2 hours of completion of surgical procedure.	—

Measure

Time frame

Main Objective: The primary objective of the trial is to assess the benefit of deep neuromuscular blockade in surgical conditions when compared to standard neuromuscular blockade in patients undergoing elective in-patient laparoscopic cholecystectomy procedures.;Secondary Objective: The key secondary trial objective is to assess whether the use of low insufflation pressure improves the overall patient's pain score within 24 hours (average of all pain assessments at 1, 2, 4 and 24 h) as compared to standard insufflation pressure, based on a standard pain scale following a laparoscopic cholecystectomy. An additional secondary objective for this study is to evaluate the visual field during laparoscopy (as determined by the surgeon) after use of sustained deep neuromuscular blockade compared to standard neuromuscular blockade. ;Primary end point(s): The Primary Endpoint for the trial is the surgeon's overall satisfaction with the surgical conditions rated at the end of the surgery using a numerical scale with scores from 0 (=poor, needed intervention) to 10 (=excellent). The Primary Efficacy Endpoint is related to the Primary Trial Objective. ;Timepoint(s) of evaluation of this end point: This evaluation will occur within 2 hours of completion of surgical procedure.

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Secondary

Measure	Time frame
Secondary end point(s): The Key Secondary Endpoint for the trial is the patient's overall reported pain as measured by a numerical scale with scores from 0 (no pain) to 10 (severe) within 24 hours (average of all pain assessments at 1, 2, 4 and 24 hours). This trial will also explore the following secondary endpoints: -Surgeon's satisfaction with the visibility of the surgical field rated at the end of the -surgery using a numerical scale with scores from 0 (unacceptable visibility) to 10 (excellent) -Surgeon's overall rating of the adequacy of muscle relaxation and insufflation pressure during surgery using a numerical scale with scores from 0 (=unacceptable muscle relaxation, required intervention) to 10 (=excellent) -Number of patient's movements that interfered with the surgical conditions during laparoscopy (includes abdominal muscle contractions, diaphragm movement, breathing/coughing against the ventilator, hiccups, patient movements) -Surgeon's assessment on the effect that these variables had on the overall surgical procedure (using numerical scale with scores of 0-10) -Number of rescue actions performed during surgery in order to improve insufficient surgical conditions -Daily assessments of patient reported overall pain and shoulder pain at rest and provoked (i.e. in connection with the transition from lying to sitting position) using a numerical scale with scores (0 to 10) starting on Day 2 up to and including the Follow-Up Visit (Day 8) -Post-operative consumption of analgesic medications ;Timepoint(s) of evaluation of this end point: Key secondary endpoint will be evaluated over 24 hours post surgery. Additional secondary endpoints will be evaluated during surgery through Day 8, depending on the endpoint.	—

Measure

Time frame

Secondary end point(s): The Key Secondary Endpoint for the trial is the patient's overall reported pain as measured by a numerical scale with scores from 0 (no pain) to 10 (severe) within 24 hours (average of all pain assessments at 1, 2, 4 and 24 hours). This trial will also explore the following secondary endpoints: -Surgeon's satisfaction with the visibility of the surgical field rated at the end of the -surgery using a numerical scale with scores from 0 (unacceptable visibility) to 10 (excellent) -Surgeon's overall rating of the adequacy of muscle relaxation and insufflation pressure during surgery using a numerical scale with scores from 0 (=unacceptable muscle relaxation, required intervention) to 10 (=excellent) -Number of patient's movements that interfered with the surgical conditions during laparoscopy (includes abdominal muscle contractions, diaphragm movement, breathing/coughing against the ventilator, hiccups, patient movements) -Surgeon's assessment on the effect that these variables had on the overall surgical procedure (using numerical scale with scores of 0-10) -Number of rescue actions performed during surgery in order to improve insufficient surgical conditions -Daily assessments of patient reported overall pain and shoulder pain at rest and provoked (i.e. in connection with the transition from lying to sitting position) using a numerical scale with scores (0 to 10) starting on Day 2 up to and including the Follow-Up Visit (Day 8) -Post-operative consumption of analgesic medications ;Timepoint(s) of evaluation of this end point: Key secondary endpoint will be evaluated over 24 hours post surgery. Additional secondary endpoints will be evaluated during surgery through Day 8, depending on the endpoint.

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Countries

Austria, Finland, Germany, Italy, United Kingdom

Contacts

Public ContactBeate Zwerdling

MSD Sharp & Dohme GmbH

beate.zwerdling@msd.de00498945611105

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026