NCT02769325

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

May 3, 2016

Last Update Submit

May 10, 2016

Conditions

Laparoscopic SurgeryGynecology

Keywords

atropinepain, postoperative

Outcome Measures

Primary Outcomes (1)

  • 24 hours morphine consumption

    morphine consumption, measured 24 post hours, in mg

    24 hours

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Atropine

EXPERIMENTAL

Patients under a standardised general surgery will receive 1mg atropine (10ml) at induction of anesthesia

Drug: AtropineDrug: SevofluraneDrug: sugammadexDrug: KetorolacDrug: Morphine PCADrug: rocuroniumDrug: propofol

placebo

PLACEBO COMPARATOR

Patients under a standardised general surgery will receive 10 ml of saline at induction of anesthesia

Drug: PlaceboDrug: SevofluraneDrug: sugammadexDrug: KetorolacDrug: Morphine PCADrug: rocuroniumDrug: propofol

Interventions

AtropineDRUG

IV atropine 0.1%, 10 ml

Atropine
PlaceboDRUG

IV saline, 10 ml

placebo
SevofluraneDRUG

All patients will receive anaesthesia based on sevoflurane, titrated to a bis of 45-60

Atropineplacebo
sugammadexDRUG

Patients will receive sugamadex for neuromuscular reversion, if necessary

Atropineplacebo
KetorolacDRUG

60 mg IV ketorolac will be administered at induction, and patients will receive 30mg/8h on the postoperative period

Atropineplacebo
Morphine PCADRUG

Patients will receive a PCA of morphine with a program of 0 (continuous infusion), 1 mg bolus and 8 minutes lockout

Atropineplacebo
rocuroniumDRUG

general anaesthesia will use rocuronium 0.6 mg/kg to facilitate intubation

Atropineplacebo
propofolDRUG

for anaesthesia induction, patients will receive 2-3 mg/kg iv propofol

Atropineplacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesia (ASA) Class I-II, gynaecological laparoscopic surgery lasting ≥30' of laparoscopic time, BMI \<35

You may not qualify if:

  • Known allergies to study drugs, concomitant surgeries, patients with closed angle glaucoma, history of coronary disease or heart insufficiency, beta.blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Santa Maria

Santiago, Chile

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

AtropineSevofluraneSugammadexKetorolacRocuroniumPropofol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsgamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydratesIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAndrostanolsAndrostanesSteroidsFused-Ring CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 11, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

August 1, 2017

Last Updated

May 11, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)