Impact of Preoperative Midazolam on Outcome of Elderly Patients (I-PROMOTE)

R

RWTH Aachen University

Status and phase

Completed
Phase 4

Conditions

Preanesthetic Medication

Treatments

Drug: Midazolam
Drug: Placebo oral capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT03052660
16-115

Details and patient eligibility

About

We aim to assess, if placebo compared to preoperative administration of midazolam in elderly patients is equal in regard to the global postoperative patient satisfaction

Full description

Generalised premedication with benzodiazepines in all surgical patients has become questionable, regarding the risk-benefit assessment and the lack of evidence for this practice. Particularly, in elderly patients (≥65 years), a higher risk for adverse events is described. Patients will be randomly assigned to one of the following two study groups. Preoperatively, group 1 will receive midazolam and group 2 will receive placebo. Anaesthesia will be performed according to the clinical routine. All possible side effects are described in the SmPC for midazolam. For the placebo-group, we do not expect any harm, as in the case of strong preoperative anxiety or agitation, additional midazolam application may occur on behalf of the attending anaesthesist at any time. The sample size was calculated based on detecting a minimum of 5 unit difference in the primary outcome variable overall patient satisfaction measured with the EVAN-G. Setting a type 1 error of 0.05, a power of 0.8 and assuming the standard deviation of EVAN-G to be 14 units, 248 patients per group are needed to detect a 5 unit difference. Considering a drop-out of 10% and a screening failure of 10%, we decided to include 614 patients in total. The hypothesis of the study is that global patient satisfaction after surgery in elderly patients is similar after preoperative placebo application compared to midazolam application.

Enrollment

782 patients

Sex

All

Ages

65 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 1. Only legally competent patients
  • Written informed consent prior to study participation
  • 65-80 years
  • Elective surgery
  • Expected surgery duration ≥ 30 minutes
  • Planned general or combined regional and general anaesthesia
  • Planned extubation at the end of surgery

Exclusion criteria

  • Age > 80 years
  • Age < 65 years
  • Non-fluency in German language
  • Alcohol and/ or drugs abuse
  • Chronic benzodiazepine treatment
  • Intracranial surgery
  • Local and stand by anaesthesia or solely regional anaesthesia
  • Monitored anaesthesia care
  • Cardiac surgery
  • Ambulatory surgery
  • Repeated surgery
  • Contraindications for benzodiazepine application (e.g. sleep apnoea syndrome, severe chronic obstructive pulmonary disease, allergy)
  • Allergy against any component of the Placebo (lactose monohydrate, cellulose powder, magnesium stearate, microcrystalline cellulose) or investigational drug (midazolam, lactose) or the capsules (gelatine, E171 titanium dioxide, E132 indigotine).
  • Expected benzodiazepine requirement after surgery
  • Expected continuous mandatory ventilation after surgery
  • Patients who explicitly request anxiolytic premedication
  • Patients with severe neurological or psychiatric disorders
  • Refusal of study participation by the patient
  • Parallel participation in interventional clinical studies within the last 30 days

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

782 participants in 2 patient groups, including a placebo group

Midazolam
Experimental group
Description:
Midazolam, 3.75 mg , oral, once, 30-45 minutes before surgery
Treatment:
Drug: Midazolam
Placebo
Placebo Comparator group
Description:
Placebo, oral, once, 30-45 minutes before surgery
Treatment:
Drug: Placebo oral capsule

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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