NCT01871922

Brief Summary

Remifentanil is a widely used potent intravenous opioid with the advantage of having a short time of action. Compared to other opiates however remifentanil generates more intense hemodynamic side-effects. In ophthalmic surgery the specific anesthesiological challenges necessitate the administration of a combination of relatively high doses of analgesics on the one hand and a short time for postoperative recovery from anesthesia on the other. For these reasons, anesthetic management often consists of a combination of relatively high doses of propofol and remifentanil. A primary concern during this deep propofol/remifentanil anesthesia is preserving hemodynamic stability and adequate tissue oxygenation. Previous research of the investigators group has revealed that atropine has an exceptionally beneficial effect on hemodynamics as well as on tissue oxygenation. Therefore, the investigators hypothesize that administration of intravenous atropine during induction of propofol/remifentanil may have a positive effect on the hemodynamic profile and peripheral and cerebral tissue oxygenation during and after induction of anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

May 30, 2013

Last Update Submit

April 15, 2024

Conditions

Anesthesia-induced Negative Hemodynamic Effects

Outcome Measures

Primary Outcomes (3)

  • Cardiac output

    During anesthesia

  • Peripheral tissue oxygen saturation

    During anesthesia

  • Cerebral tissue oxygen saturation

    During anesthesia

Secondary Outcomes (3)

  • Heart rate

    During anesthesia

  • Mean arterial blood pressure

    During anesthesia

  • Systemic vascular resistance

    During anesthesia

Study Arms (2)

General anesthesia + placebo

PLACEBO COMPARATOR

Propofol/remifentanil anesthesia + saline

Drug: Placebo

General anesthesia + atropine

ACTIVE COMPARATOR

Propofol/remifentanil anesthesia + atropine

Drug: Atropine

Interventions

PlaceboDRUG

Saline

Also known as: Saline
General anesthesia + placebo
AtropineDRUG

Atropine

General anesthesia + atropine

Eligibility Criteria

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

You may qualify if:

  • Patients requiring general anaesthesia;
  • Patient's age ≥ 18 years and older;
  • Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.

You may not qualify if:

  • Patient's refusal;
  • Pregnancy;
  • Patient's age \< 18 years;
  • Patients in which atropine is contra-indicated, such as severe aortic valve stenosis, hypertrophic cardiomyopathy or coronary artery disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

Related Publications (1)

  • Poterman M, Scheeren TWL, van der Velde MI, Buisman PL, Allaert S, Struys MMRF, Kalmar AF. Prophylactic atropine administration attenuates the negative haemodynamic effects of induction of anaesthesia with propofol and high-dose remifentanil: A randomised controlled trial. Eur J Anaesthesiol. 2017 Oct;34(10):695-701. doi: 10.1097/EJA.0000000000000639.

    PMID: 28403018DERIVED

MeSH Terms

Interventions

Sodium ChlorideAtropine

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsAtropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Alain F Kalmar, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 7, 2013

Study Start

October 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations

NL(1)