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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
IV atropine 0.1%, 10 ml
IV saline, 10 ml
All patients will receive anaesthesia based on sevoflurane, titrated to a bis of 45-60
Clinica Santa Maria
Santiago, Chile
24 hours morphine consumption
morphine consumption, measured 24 post hours, in mg
Time frame: 24 hours
Pain Visual analog scale at 24 hours
Time frame: 24 hours
pain visual analog scale at postanesthesia care unit
Time frame: 2 hours post
number of patients with postoperative nausea and/or vomiting
Time frame: 24 hours
Patient satisfaction, on a qualitative scale
Time frame: up to three days
number of patients that refer palpitations
Time frame: 24 hours
number of patients that refer mouth dryness
Time frame: 24 hours
number of patients that refer blurred vision
Time frame: 24 hours
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Patients will receive sugamadex for neuromuscular reversion, if necessary
60 mg IV ketorolac will be administered at induction, and patients will receive 30mg/8h on the postoperative period
Patients will receive a PCA of morphine with a program of 0 (continuous infusion), 1 mg bolus and 8 minutes lockout
general anaesthesia will use rocuronium 0.6 mg/kg to facilitate intubation
for anaesthesia induction, patients will receive 2-3 mg/kg iv propofol