Measurement of Psychomotor Recovery After Anesthesia Using 4CRT

NCT02232139 | Completed Phase 2

• 2 other identifiers: BR-87/13-1EK-BR-87/13-1
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the investigation is to validate the SmartPhone-based 4-Reaction Choice Time Test (4CRT) as a measure for recovery of the psychomotor function in patients after general anesthesia. One hundred female patients, scheduled to ambulatory gynecological surgery in general anesthesia, will be randomized to the group with pharmacological anxiolytic premedication with midazolam (N=50) and to the group without midazolam (N=50). All patients will be monitored using 4CRT before and after standardized general anesthesia. The reaction time, measured with 4CRT is the primary outcome parameter of the investigation.

Conditions

Delayed Recovery From Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Change of four choice reaction time from baseline

  One time immediately before the surgery and 6 times within 2 hours after the surgery for each participant

  One time before the surgery and 2 hours after the surgery

Secondary Outcomes (1)

• Concentration of midazolam in serum

  Within 2 hours after the surgery only in 40 (20 from each group) participants

Other Outcomes (1)

• Postanesthesia discharge scoring system

  Within 2 hours after the surgery

Study Arms (2)

Standard therapy group

NO INTERVENTION

Participant who will not receive midazolam for pharmacological anxiolytic premedication before general surgery

Midazolam group

EXPERIMENTAL

Participant who will receive midazolam for pharmacological anxiolytic premedication before general surgery

Drug: Midazolam

Interventions

Midazolam DRUG

The participants receive the pharmacological premedication before the surgery anyway

Also known as: Dormicum

Midazolam group

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physical status I-III according to American Society of Anesthesiology
• ambulatory gynecologic surgery of 10-40 min
• patient is able to use VAS and to use SmartPhone-based 4CRT
• given informed consent

You may not qualify if:

• age \< 18 or \> 50 years
• patients who are not able to give their informed consent
• surgery lasts more than 40 min.
• history of psychopharmaceuticals or analgesics

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Department of Anesthesiology, Hospital Dresden-Friedrichstadt, Dresden, Germany: collaborator

Study Sites (1)

Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy

Dresden, Saxony, 01067, Germany

Location

Related Publications (1)

• Zuurmond WW, Balk VA, van Dis H, van Leeuwen L, Paul EA. Multidimensionality of psychological recovery from anaesthesia. Analysing six recovery tests. Anaesthesia. 1989 Nov;44(11):889-92. doi: 10.1111/j.1365-2044.1989.tb09141.x.

  PMID: 2596654 BACKGROUND

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Taras I Usichenko, MD, PhD

  University Medicine of Greifswald

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 5, 2014
• Study Start: March 1, 2016
• Primary Completion: June 25, 2019
• Study Completion: June 25, 2019
• Last Updated: January 11, 2021

Record last verified: 2021-01

Locations

DE (1)