Laparoscopic Surgery, Gynecology
Conditions
Keywords
atropine, pain, postoperative
Brief 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
Interventions
DRUGAtropine
IV atropine 0.1%, 10 ml
DRUGPlacebo
IV saline, 10 ml
DRUGSevoflurane
All patients will receive anaesthesia based on sevoflurane, titrated to a bis of 45-60
DRUGsugammadex
Patients will receive sugamadex for neuromuscular reversion, if necessary
DRUGKetorolac
60 mg IV ketorolac will be administered at induction, and patients will receive 30mg/8h on the postoperative period
DRUGMorphine PCA
Patients will receive a PCA of morphine with a program of 0 (continuous infusion), 1 mg bolus and 8 minutes lockout
DRUGrocuronium
general anaesthesia will use rocuronium 0.6 mg/kg to facilitate intubation
DRUGpropofol
for anaesthesia induction, patients will receive 2-3 mg/kg iv propofol
Sponsors
Clinica Santa Maria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24 hours morphine consumption | 24 hours | morphine consumption, measured 24 post hours, in mg |
Secondary
| Measure | Time frame |
|---|---|
| pain visual analog scale at postanesthesia care unit | 2 hours post |
| number of patients with postoperative nausea and/or vomiting | 24 hours |
| Patient satisfaction, on a qualitative scale | up to three days |
| Pain Visual analog scale at 24 hours | 24 hours |
| number of patients that refer mouth dryness | 24 hours |
| number of patients that refer blurred vision | 24 hours |
| number of patients that refer palpitations | 24 hours |
Countries
Chile
Outcome results
None listed