Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade

Neuromuscular Blockade Clinical Trial

Official title:

Optimizing Surgical Conditions: Intraabdominal Distance During Gynecologic Laparoscopic Surgery With and Without Muscle Relaxation (The Measurement Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933425
• Other study ID #: NMBDK2013
• Secondary ID: 2013-001164-29
• Status: Completed
• Phase: Phase 4
• First received: August 28, 2013
• Last updated: March 27, 2015
• Start date: August 2013
• Est. completion date: April 2014

Study information

• Verified date: March 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with pneumoperitoneum 12 mmHg.

Hypothesis:

Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to skin surface, cm) compared to no neuromuscular blockade.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients > 18 years old

• elective laparoscopic operation

• can read and understand Danish

• informed consent

Exclusion Criteria:

• BMI > 30 kg/cm2

• known allergy to medications that are included in the project,

• severe renal disease, defined by S-creatinine> 0,200 mmol/L, GFR < 30ml/min or hemodialysis),

• neuromuscular disease that may interfere with neuromuscular data,

• lactating or pregnant,

• impaired liver function,

• converting to laparotomy,

• perioperative use of neuromuscular blocking agents before randomization,

• pneumoperitoneum set to >12 mmHg on the insufflator

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• rocuronium

• sugammadex

• placebo

Locations

Country	Name	City	State
Denmark	Department of minimal invasive gynecology Aleris-Hamlet Private Hospital	Copenhagen	Søborg

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraabdominal Distance (Centimeters)	Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1).	1 hour	No
Secondary	Intraabdominal Distance (Centimeters)	Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1).	1 hour	No
Secondary	Surgical Conditions During Suturing of the Abdominal Fascia	Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4)	1 hour	No