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Atropine-effect During Propofol/Remifentanil Induction

Sponsor
University Medical Center Groningen (Other)
Overall Status
Completed
CT.gov ID
NCT01871922
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
8
Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Effects of the Addition of Atropine During Propofol/Remifentanil Induction of Anesthesia on Hemodynamics, Microvascular Blood Flow and Tissue Oxygenenation in Patients Undergoing Ophthalmic Surgery
Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: General anesthesia + placebo

Propofol/remifentanil anesthesia + saline

Drug: Placebo
Saline
Other Names:
  • Saline

    		•
    Active Comparator: General anesthesia + atropine

    Propofol/remifentanil anesthesia + atropine

    Drug: Atropine
    Atropine

    Outcome Measures

    Primary Outcome Measures

    1. Cardiac output [During anesthesia]

    2. Peripheral tissue oxygen saturation [During anesthesia]

    3. Cerebral tissue oxygen saturation [During anesthesia]

    Secondary Outcome Measures

    1. Heart rate [During anesthesia]

    2. Mean arterial blood pressure [During anesthesia]

    3. Systemic vascular resistance [During anesthesia]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients requiring general anaesthesia;

    • Patient's age ≥ 18 years and older;

    • Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Groningen Groningen Netherlands 9713GZ

    Sponsors and Collaborators

    • University Medical Center Groningen

    Investigators

    • Principal Investigator: Alain F Kalmar, MD, PhD, University Medical Center Groningen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    A.F.Kalmar, MD, PhD, University Medical Center Groningen
    ClinicalTrials.gov Identifier:
    NCT01871922
    Other Study ID Numbers:
    • Retro-002
    First Posted:
    Jun 7, 2013
    Last Update Posted:
    Jan 31, 2014
    Last Verified:
    Jan 1, 2014
    Additional relevant MeSH terms:
    Atropine

    Study Results

    No Results Posted as of Jan 31, 2014