Atropine in Laparoscopic Gynaecological Surgery

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

Inclusion Criteria:

• American Society of Anesthesia (ASA) Class I-II, gynaecological laparoscopic surgery lasting ≥30' of laparoscopic time, BMI <35

Exclusion Criteria:

• Known allergies to study drugs, concomitant surgeries, patients with closed angle glaucoma, history of coronary disease or heart insufficiency, beta.blockers