Laparoscopic Surgery Clinical Trial
Official title:
Atropine in Laparoscopic Gynaecological Surgery (The ALGOS Trial) A Randomised, Double Blind, Controlled Trial
This is a double blinded, randomised controlled trial that will compare atropine to placebo for postoperative pain in laparoscopic gynaecological surgery
Patients that meet eligibility criteria will receive a standardised general anesthesia based
on sevoflurane and opioids and will be randomised in two groups, using computer generated
randomisation system. Allocation concealment is established on opaque envelopes that contain
random allocation.
Anesthesia depth will be measured by Bispectral index (BIS), titration of sevoflurane to a
BIS of 45-60. In case of neuromuscular block reversal at the end of surgery, sugammadex will
be administered.
At induction, 1 mg IV atropine 0.1% OR 10ml saline will be administered, depending on group
allocation, on a syringe prepared by an anaesthesiologist not involved in the study.
Patients will receive ketorolac 30 mg/8h, acetaminophen 1g/8h and a morphine IV patient
controlled anaesthesia pump (PCA) 0-1-8 Outcomes will be evaluated at the postoperative care
unit (PACU) and 24 postoperative hours by an investigator blinded to study group
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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