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Atropine in Laparoscopic Gynaecological Surgery (ALGOS)

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ClinicalTrials.gov Identifier: NCT02769325
Recruitment Status : Unknown
Verified May 2016 by David Torres, Clinica Santa Maria.
Recruitment status was:  Not yet recruiting
First Posted : May 11, 2016
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
David Torres, 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

Condition or disease Intervention/treatment Phase
Laparoscopic Surgery Gynecology Drug: Atropine Drug: Placebo Drug: Sevoflurane Drug: sugammadex Drug: Ketorolac Drug: Morphine PCA Drug: rocuronium Drug: propofol Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Atropine in Laparoscopic Gynaecological Surgery (The ALGOS Trial) A Randomised, Double Blind, Controlled Trial
Study Start Date : May 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


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: Placebo
IV saline, 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




Primary Outcome Measures :
  1. 24 hours morphine consumption [ Time Frame: 24 hours ]
    morphine consumption, measured 24 post hours, in mg


Secondary Outcome Measures :
  1. Pain Visual analog scale at 24 hours [ Time Frame: 24 hours ]
  2. pain visual analog scale at postanesthesia care unit [ Time Frame: 2 hours post ]
  3. number of patients with postoperative nausea and/or vomiting [ Time Frame: 24 hours ]
  4. Patient satisfaction, on a qualitative scale [ Time Frame: up to three days ]
  5. number of patients that refer palpitations [ Time Frame: 24 hours ]
  6. number of patients that refer mouth dryness [ Time Frame: 24 hours ]
  7. number of patients that refer blurred vision [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769325


Locations
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Chile
Clinica Santa Maria
Santiago, Chile
Sponsors and Collaborators
Clinica Santa Maria

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Responsible Party: David Torres, Principal Investigator, Clinica Santa Maria
ClinicalTrials.gov Identifier: NCT02769325    
Other Study ID Numbers: CSM2016001
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Torres, Clinica Santa Maria:
atropine
pain, postoperative
Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Atropine
Morphine
Anesthetics
Propofol
Sevoflurane
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action