Atropine in Laparoscopic Gynaecological Surgery (ALGOS)

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

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

Study Overview

• Status: Unknown
• Conditions: Laparoscopic Surgery; Gynecology
• Intervention / Treatment: Drug: Atropine; Drug: Sevoflurane; Drug: sugammadex; Drug: Ketorolac; Drug: Morphine PCA; Drug: rocuronium; Drug: propofol; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Clinica Santa Maria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atropine; Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia	Drug: Atropine; IV atropine 0.1%, 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
Placebo Comparator: placebo; Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia	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; Drug: Placebo; IV saline, 10 ml

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Clinica Santa Maria

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: atropine; pain, postoperative
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anesthetics, Inhalation; Neuromuscular Agents; Mydriatics; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Propofol; Ketorolac; Sevoflurane; Morphine; Rocuronium; Atropine
• Other Study ID Numbers: CSM2016001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO