Clinical trial NCT01871922: Atropine-effect During Propofol/Remifentanil Induction
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia-induced Negative Hemodynamic Effects
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cardiac output
timeFrame: During anesthesia
measure: Peripheral tissue oxygen saturation
timeFrame: During anesthesia
measure: Cerebral tissue oxygen saturation
timeFrame: During anesthesia
Secondary outcomes:
measure: Heart rate
timeFrame: During anesthesia
measure: Mean arterial blood pressure
timeFrame: During anesthesia
measure: Systemic vascular resistance
timeFrame: During anesthesia
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Alain F Kalmar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.