Atropine in Laparoscopic Gynaecological Surgery

Laparoscopic Surgery Clinical Trial

— ALGOS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02769325
• Other study ID #: CSM2016001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 3, 2016
• Last updated: May 10, 2016
• Start date: May 2016
• Est. completion date: August 2017

Study information

• Verified date: May 2016
• Source: Clinica Santa Maria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gynecology
• Laparoscopic Surgery

Intervention

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

Locations

Country	Name	City	State
Chile	Clinica Santa Maria	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Santa Maria

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hours morphine consumption	morphine consumption, measured 24 post hours, in mg	24 hours	No
Secondary	Pain Visual analog scale at 24 hours		24 hours	No
Secondary	pain visual analog scale at postanesthesia care unit		2 hours post	No
Secondary	number of patients with postoperative nausea and/or vomiting		24 hours	No
Secondary	Patient satisfaction, on a qualitative scale		up to three days	No
Secondary	number of patients that refer palpitations		24 hours	Yes
Secondary	number of patients that refer mouth dryness		24 hours	Yes
Secondary	number of patients that refer blurred vision		24 hours	Yes