The primary objective of this trial is to compare the preference between two strategies of
neuromuscular blocking (NMB) / reversal in adult obese patients undergoing laparoscopic
abdominal surgery: Rocuronium + Sugammadex versus Succinylcholine + Cisatracurium +
Neostigmine/Atropine. This will be done evaluating the average verbal numerical scale (VNS)
scores obtained from surgeons blinded to the drugs administered. The primary hypothesis is
that the strategy "Rocuronium + Sugammadex" provides a better surgical visual field in obese
participants undergoing laparoscopic abdominal surgery than the strategy "Succinylcholine +
Cisatracurium + Neostigmine/Atropine" as measured by VNS scores.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- must be obese, with a Body Mass Index ≥30. 0 to ≤50.
- must be scheduled to undergo an elective abdominal laparoscopic surgery, under
general anesthesia. (Participants are expected to remain in the hospital for at least
24 hours following surgical procedure.)
- must be categorized as American Society of Anesthesiologists (ASA) Class 1, 2, or 3.
- clinical laboratory tests within normal limits or clinically acceptable to the
investigator/sponsor.
- sexually active females of child-bearing potential must agree to use a medically
accepted method of contraception while receiving protocol-specified medication and
for the 30 days after stopping the medication. Medically accepted methods of
contraception include condoms (male or female) with or without a spermicidal agent,
diaphragm or cervical cap with spermicide, medically prescribed IUD, inert or
copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptive, and
surgical sterilization (eg, hysterectomy or tubal ligation). Postmenopausal women are
not required to use contraception. Postmenopausal is defined as at least 12
consecutive months without a spontaneous menstrual period. Each sexually active male
subject with a female partner(s) of childbearing potential must also provide written
informed consent to provide information regarding any pregnancy.
Exclusion Criteria:
- has anatomical malformations that may lead to difficult intubation.
- is known or suspected to have neuromuscular disorders that may affect NMB and/or
trial assessments.
- history of previous abdominal laparoscopy procedures.
- must not currently (within past 6 months) meet DSM-IV-TR criteria for substance abuse
or dependence (excluding nicotine).
- history of a chronic pain condition (requiring continuous/daily pain medication prior
to surgery).
- females who have given birth to one or more children in the last 12 months, or are
pregnant or intend to become pregnant between randomization and >Day 30 pregnancy
follow-up contact [premenopausal female of childbearing potential].
- evidence of acute cholecystitis.
- dialysis-dependency or suspected of having severe renal insufficiency (defined as
estimated creatinine clearance of <30 mL/min).
- significant hepatic dysfunction that would prevent participation in the trial, based
on the summary of product characteristics of the study drugs.
- history of or family history of malignant hyperthermia.
- known allergy to trial treatments (rocuronium, sugammadex, succinylcholine,
cisatracurium, neostigmine, atropine) or their excipients, to opioids/opiates, or
other medication used during general anesthesia.
- expected transfer to intensive care unit after surgery.
- must continue to receive toremifene or fusidic acid during the trial.
- has participated in another clinical trial within 30 days of signing the informed
consent form of the current trial.