Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli

Anaesthesia Clinical Trial

Official title:

The Effect of Dexmedetomidine on Reactivity to Noxious Stimuli During Propofol-remifentanil Anaesthesia and Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076790
• Other study ID #: Kotoe_01
• Secondary ID: 2009-014619-11
• Status: Completed
• Phase: Phase 4
• First received: February 25, 2010
• Last updated: October 8, 2013
• Start date: November 2009
• Est. completion date: March 2011

Study information

• Verified date: October 2013
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

Dexmedetomidine acts at central nervous system (specifically: at locus caeruleus), providing sedative and analgesic effects. It is widely used in intensive care. Surgery-related interventions elicit arousal ('nociceptive') reactions. The effects of dexmedetomidine on the neurophysiological signs of arousal are studied in surgical patients. Brain waves, electrocardiogram, Entropy Index, Bispectral Index, and fingertip pulse waves are recorded and analyzed later on. The course of anaesthesia and surgery are recorded.

Description:

The patients are randomized to receive either dexmedetomidine or saline infusion before and during anaesthesia (dexmedetomidine 0.1 mcg/kg within 10 minutes, thereafter 0.7 mcg/kg/h until 30 min after skin incision).

Multi-channel EEG, Entropy, BIS, multi-channel EMG, ECG, and plethysmogram are recorded on computer. Anaesthesia and surgery associated events are annotated on computer.

Time points of endotracheal intubation, skin incision, and course of surgery well be analyzed in detail. Additionally, tetanic stimulus of ulnar nerve will be applied for each patient, and reactions to the stimulus will be analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• males or females giving informed consent

• age range 18-70 years

• elective surgery: laparoscopy, laparotomy, breast surgery

• general anaesthesia

• ASA classification 1 or 2

Exclusion Criteria:

• pregnancy

• body mass index 30.1 or more

• diseases affecting CNS, autonomic nervous system, heart, heart rate, or circulation

• chronic use of drugs affecting CNS, autonomic nervous system, heart, heart rate, or circulation; except antihypertensives, which are acceptable in this study

• chronic use of clonidine

• serious psychiatric disease or condition

• overuse of alcohol

• use of illicit drugs

• unability of understand, read or use Finnish language

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anaesthesia

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.
• Saline
Saline infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Arvi Yli-Hankala

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological reaction to noxious stimulus	Nociception-associated changes in EEG, EMG, Entropy Index values, BIS Index values, morphology of plethysmogram or ECG, heart rate, or hear rate variability.	30 minutes	No