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Atropine-effect During Propofol/Remifentanil Induction

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01871922
Enrollment
60
Registered
2013-06-07
Start date
2012-10-31
Completion date
2013-06-30
Last updated
2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia-induced Negative Hemodynamic Effects

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.

Interventions

DRUGPlacebo

Saline

DRUGAtropine

Atropine

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Cardiac outputDuring anesthesia
Peripheral tissue oxygen saturationDuring anesthesia
Cerebral tissue oxygen saturationDuring anesthesia

Secondary

MeasureTime frame
Systemic vascular resistanceDuring anesthesia
Heart rateDuring anesthesia
Mean arterial blood pressureDuring anesthesia

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026