Changes of Skin Resistance After Midazolam and After the End of Anaesthesia

NCT03791424 | Completed Phase 4

• 1 other identifier: Oxytocin01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

It has been described that sympathetic activity, measured as changes in electrical skin resistance (SR), may be used to assess the adequacy of general anaesthesia. Our prospective study investigated how far measurements of skin resistance can help determine level of sedation. The secondary aim was to investigate if changes in skin resistance can be used for assessing recovery from anaesthesia.

Conditions

Anesthesia

Keywords

sedation; midazolam; skin resistance; measurements

Outcome Measures

Primary Outcomes (1)

• Changes of skin resistence (percent from base-line values measured in ohms) during sedation

  Investigation how far measurements of skin resistance can help determine level of sedation induced by intravenous midazolam

  10 min. before administration and 5 min. after administration of midazolam (total 15 min.)

Secondary Outcomes (1)

• Changes of skin resistence (percent from base-line values and values before termination of inhalational agent administration measured in ohms) during recovery from anaesthesia

  From termination of inhalational agent administration till recovery to verbal comunication (expected time max. 15 min)

Study Arms (2)

Midazolam

EXPERIMENTAL

Midazolam 2 mg was administered 5 min. after placebo and 5 min. before inducton to general anaesthesia IV.

Drug: Midazolam

Control

PLACEBO COMPARATOR

Normal saline 5 ml was administered 10 min. after insertion of intravenous cannula IV..

Drug: Midazolam

Interventions

Midazolam DRUG

Administering premedication with sedative drug to relieve anxiety

Also known as: Sedation

Control; Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients scheduled for knee arthroscopy or minor plastic surgery under general anaesthesia

You may not qualify if:

• previous history of taking drugs affecting mental functions, history of psychic illness, implanted electrical device, know allergy to benzodiazepines, myasthenia gravis, ASA classification ASA 3 and more. All patients consented not to use any medication for sedation or anxiety, opioid analgesics, ethanol and illicit drugs 24 hours before surgery.

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

University Hospital Kralovske Vinohrady

Prague, 100 00, Czechia

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jiri Malek, M.D.

  University Hospital Kralovske Vinohrady

  PRINCIPAL INVESTIGATOR

• Alice Kurzova, M.D.

  University Hospital Kralovske Vinohrady

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo of the same volume and colour as active substance
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prfo. Jiri Malek, CSc.

Model Details: Multimeter DM 3900 was used for measurements of SR. The device was approved for use in humans by the Department of Medical Biophysics and Informatics of the 3rd Medical Faculty of Charles University. Observer's Assessment of Alertness and Sedation scale was used as a standard tool for measurements of sedation level at the same intervals as measurements of SR. 10 min. rest break was given to participants in order that they adapt to the test situation. The rest value of SR was noticed and next all patients were administered placebo first and after 5 min period midazolam 2 mg i.v. After next 5 minutes patients were administered standard general anaesthesia with propofol, oxygen, nitrous oxide 60 % and isoflurane 1 MAC via laryngeal mask and sufentanil as needed. Changes in skin resistance were measured again immediately after stop of volatile anaesthetics till eye opening and verbal contact.

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: January 2, 2019
• Study Start: October 1, 2014
• Primary Completion: June 26, 2015
• Study Completion: June 26, 2015
• Last Updated: January 3, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)