Atropine-effect During Propofol/Remifentanil Induction

Anesthesia-induced Negative Hemodynamic Effects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871922
• Other study ID #: Retro-002
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: April 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia-induced Negative Hemodynamic Effects

Intervention

Drug:
• Placebo
Saline
• Atropine
Atropine

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output		During anesthesia
Primary	Peripheral tissue oxygen saturation		During anesthesia
Primary	Cerebral tissue oxygen saturation		During anesthesia
Secondary	Heart rate		During anesthesia
Secondary	Mean arterial blood pressure		During anesthesia
Secondary	Systemic vascular resistance		During anesthesia