Atropine in Laparoscopic Gynaecological Surgery (ALGOS)

Clinica Santa Maria

Status and phase: Unknown; Phase 4

Conditions: Laparoscopic Surgery; Gynecology

Treatments: Drug: Ketorolac; Drug: Placebo; Drug: Sevoflurane; Drug: Atropine; Drug: sugammadex; Drug: propofol; Drug: Morphine PCA; Drug: rocuronium

Study type: Interventional

Funder types: Other

Identifiers

NCT02769325

CSM2016001

Details and patient eligibility

About

This is a double blinded, randomised controlled trial that will compare atropine to placebo for postoperative pain in laparoscopic gynaecological surgery

Full description

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

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Atropine

Experimental group

Description:

Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia

Treatment:

Drug: Ketorolac

Drug: Atropine

Drug: rocuronium

Drug: Sevoflurane

Drug: propofol

Drug: Morphine PCA

Drug: sugammadex

placebo

Placebo Comparator group

Description:

Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia

Treatment:

Drug: Ketorolac

Drug: Placebo

Drug: rocuronium

Drug: Sevoflurane

Drug: propofol

Drug: Morphine PCA

Drug: sugammadex