Atropine in Laparoscopic Gynaecological Surgery
- Conditions
- GynecologyLaparoscopic Surgery
- Interventions
- Registration Number
- NCT02769325
- Lead Sponsor
- Clinica Santa Maria
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 150
- American Society of Anesthesia (ASA) Class I-II, gynaecological laparoscopic surgery lasting ≥30' of laparoscopic time, BMI <35
- Known allergies to study drugs, concomitant surgeries, patients with closed angle glaucoma, history of coronary disease or heart insufficiency, beta.blockers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia Atropine Sevoflurane Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia placebo Morphine PCA Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia Atropine Atropine Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia Atropine Morphine PCA Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia Atropine sugammadex Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia Atropine Ketorolac Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia Atropine rocuronium Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia Atropine propofol Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia placebo sugammadex Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia placebo Sevoflurane Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia placebo Ketorolac Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia placebo rocuronium Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia placebo propofol Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia
- Primary Outcome Measures
Name Time Method 24 hours morphine consumption 24 hours morphine consumption, measured 24 post hours, in mg
- Secondary Outcome Measures
Name Time Method Pain Visual analog scale at 24 hours 24 hours pain visual analog scale at postanesthesia care unit 2 hours post Patient satisfaction, on a qualitative scale up to three days number of patients with postoperative nausea and/or vomiting 24 hours number of patients that refer palpitations 24 hours number of patients that refer blurred vision 24 hours number of patients that refer mouth dryness 24 hours
Trial Locations
- Locations (1)
Clinica Santa Maria
🇨🇱Santiago, Chile