Obese adults to be subjected to abdominal laparoscopic surgery
Conditions
Interventions
Trade Name: Bridion ® 2ml SOLUZIONE INIETTABILE USO ENDOVENOSO FLACONCINO
Bridion ® 5ml SOLUZIONE INIETTABILE USO ENDOVENOSO FLACONCINO
Product Name: Bridion ®
Product Code: MK8616
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sugammadex
Other descriptive name: SUGAMMADEX
Concentration unit: mg/kg milligram(s)/kilog
Sponsors
MSD Italia s.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient should be obese, defined as Body Mass Index =30.0 ? The patient should be scheduled for elective laparoscopic abdominal surgery with general anesthesia ? The patient should be classified as ASA Class 1, 2, or 3 ? The patient should be able to understand the questionnaires in order to give reliable answers ? The patient must have an arm accessible during surgery for the monitoring of the block with the TOF Watch SX® that will be used for the purpose of monitoring neuro-muscular transmission ? The patient should have the results of laboratory tests (CBC, biochemistry) within normal limits or clinically acceptable to the investigator / sponsor ? The patient must have the results of the physical examination, including blood pressure within normal limits or clinically acceptable to the investigator / sponsor 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 178 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? The patient malformations that could embarrass the intubation ? The patient has neuromuscular disorders that can affect the neuro-muscular blocking and / or assessments of the study ? The patient has already made other abdominal laparoscopic procedures ? The patient has no history of chronic pain, defined as opioids or NSAIDs within 7 days before surgery ? Female patients of childbearing age who have given birth in the previous 12 months or are pregnant or plan to become pregnant between randomization and the contact of Day 30 pregnancy follow-up ? The patient has evidence of acute cholecystitis ? The patient dialysis-dependent renal failure or has suspected severe renal impairment (defined as estimated creatinine clearance <30 mL / min). ? significant hepatic dysfunction, which may prevent the patient to participate in the study by the investigator based on the RCP of the study drugs ? The patient has a history or family history of malignant hypothermia ? The patient has a known allergy to the study treatments or their ingredients, opioids / opiates, or other medicines used during general anesthesia ? Transfer UCI after surgery ? The patient received one of the treatments in Table 1, more recently, by the period of wash-out ? The patient should continue taking during the study one of the treatments listed in Table 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the preference between the two strategies and reversal of neuromuscular blockade in obese adults to be subjected to abdominal laparoscopic surgery. This will be done by evaluating the average of the scores obtained by the VNS surgeons blinded to the drugs administered.;Secondary Objective: The main secondary objectives of the study are to compare between the two groups, (1) the time between the end of surgery and the time to extubation, (2) The time that elapses between administration of the reversal and the TOFR> 0.9;Primary end point(s): The primary objective of this study is to compare the preference between the two strategies and reversal of neuromuscular blockade in obese adults to be subjected to abdominal laparoscopic surgery. This will be done by evaluating the average of the scores obtained by the VNS surgeons blinded to the drugs administered.;Timepoint(s) of evaluation of this end point: Detection time will be at the end of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) the time between the end of surgery and the time to extubation, (2) The time that elapses between administration of the reversal and the TOFr=0.9. Other secondary efficacy endpoints are (1) The total time of use of the operating room compared between the two groups; (2) a comparison of the time-point between the two groups in the average value of the preference of patients, collected by QoR score; (3) comparison between the groups of a "comprehensive anesthesia score" average, to be collected by the anesthetist when the patient leaves the PACU (if available) or the operating room, consisting of answers to some questions relating to the management and events occurred during the procedure; (4) comparison between groups of time to achieve a modified Aldrete score> 9 in two successive assessments prior to discharge from the PACU (if available) or from the operating room.;Timepoint(s) of evaluation of this end point: The detection time is between the end of surgery and discharge from the PACU operating room. | — |
Countries
Italy
Contacts
Public ContactDivisione Ricerca Clinica
MSD Italia s.r.l
Outcome results
None listed