NCT02769325

Atropine in Laparoscopic Gynaecological Surgery

Atropine in Laparoscopic Gynaecological Surgery (The ALGOS Trial) A Randomised, Double Blind, Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Clinica Santa Maria · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Laparoscopic Surgery
• Gynecology

Interventions

Type	Name	Description
DRUG	Atropine	IV atropine 0.1%, 10 ml
DRUG	Placebo	IV saline, 10 ml
DRUG	Sevoflurane	All patients will receive anaesthesia based on sevoflurane, titrated to a bis of 45-60
DRUG	sugammadex	Patients will receive sugamadex for neuromuscular reversion, if necessary
DRUG	Ketorolac	60 mg IV ketorolac will be administered at induction, and patients will receive 30mg/8h on the postoperative period
DRUG	Morphine PCA	Patients will receive a PCA of morphine with a program of 0 (continuous infusion), 1 mg bolus and 8 minutes lockout
DRUG	rocuronium	general anaesthesia will use rocuronium 0.6 mg/kg to facilitate intubation
DRUG	propofol	for anaesthesia induction, patients will receive 2-3 mg/kg iv propofol

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-05-01
• Completion: 2017-08-01
• First posted: 2016-05-11
• Last updated: 2016-05-11

Locations

1 site across 1 country: Chile