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Atropine-effect During Propofol/Remifentanil Induction

U

University Medical Center Groningen (UMCG)

Status

Completed

Conditions

Anesthesia-induced Negative Hemodynamic Effects

Treatments

Drug: Placebo
Drug: Atropine

Study type

Interventional

Funder types

Other

Identifiers

NCT01871922
Retro-002

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups, including a placebo group

General anesthesia + placebo
Placebo Comparator group
Description:
Propofol/remifentanil anesthesia + saline
Treatment:
Drug: Placebo
General anesthesia + atropine
Active Comparator group
Description:
Propofol/remifentanil anesthesia + atropine
Treatment:
Drug: Atropine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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