A Study Comparing the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures in Participants Undergoing Laparoscopic Cholecystectomy (P07982)

PHASE4CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

November 28, 2012

Primary Completion Date

April 29, 2014

Study Completion Date

April 29, 2014

Conditions
Gallbladder Disease
Interventions
DRUG

Rocuronium

NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium. NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition. - Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted TOF ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%). - Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC).

OTHER

Insufflation

"Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity.~* Standard insufflation pressure - a starting pressure of 12 mmHg will be used.~* Low insufflation pressure - a starting pressure of 8 mmHg will be used."

DRUG

Sugammadex

NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex.

Trial Locations (2)

Unknown

Merck Sharp & Dohme GmbH, Haar

MSD Italia S.r.l., Rome

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01728584 - A Study Comparing the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures in Participants Undergoing Laparoscopic Cholecystectomy (P07982) | Biotech Hunter | Biotech Hunter