Atropine in Laparoscopic Gynaecological Surgery

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

Detailed Description
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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

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

Conditions
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Laparoscopic Surgery, Gynecology

Intervention / Treatment
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* Drug: Atropine
* Drug: Placebo
* Drug: Sevoflurane
* Drug: sugammadex
* Drug: Ketorolac
* Drug: Morphine PCA
* Drug: rocuronium
* Drug: propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atropine<br>Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia | Drug: Atropine<br>* IV atropine 0.1%, 10 ml<br>Drug: Sevoflurane<br>* All patients will receive anaesthesia based on sevoflurane, titrated to a bis of 45-60<br>Drug: sugammadex<br>* Patients will receive sugamadex for neuromuscular reversion, if necessary<br>Drug: Ketorolac<br>* 60 mg IV ketorolac will be administered at induction, and patients will receive 30mg/8h on the postoperative period<br>Drug: Morphine PCA<br>* Patients will receive a PCA of morphine with a program of 0 (continuous infusion), 1 mg bolus and 8 minutes lockout<br>Drug: rocuronium<br>* general anaesthesia will use rocuronium 0.6 mg/kg to facilitate intubation<br>Drug: propofol<br>* for anaesthesia induction, patients will receive 2-3 mg/kg iv propofol<br>|
| Placebo Comparator: placebo<br>Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia | Drug: Placebo<br>* IV saline, 10 ml<br>Drug: Sevoflurane<br>* All patients will receive anaesthesia based on sevoflurane, titrated to a bis of 45-60<br>Drug: sugammadex<br>* Patients will receive sugamadex for neuromuscular reversion, if necessary<br>Drug: Ketorolac<br>* 60 mg IV ketorolac will be administered at induction, and patients will receive 30mg/8h on the postoperative period<br>Drug: Morphine PCA<br>* Patients will receive a PCA of morphine with a program of 0 (continuous infusion), 1 mg bolus and 8 minutes lockout<br>Drug: rocuronium<br>* general anaesthesia will use rocuronium 0.6 mg/kg to facilitate intubation<br>Drug: propofol<br>* for anaesthesia induction, patients will receive 2-3 mg/kg iv propofol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hours morphine consumption | morphine consumption, measured 24 post hours, in mg | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Visual analog scale at 24 hours |  | 24 hours | 
| 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 | 
| number of patients that refer palpitations |  | 24 hours | 
| number of patients that refer mouth dryness |  | 24 hours | 
| number of patients that refer blurred vision |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atropine, pain, postoperative