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Clinical Trials/ACTRN12614000169640
ACTRN12614000169640
Completed
Phase 1

Comparison of Analgesia Nociception Index (ANI) guided analgesia administration with Standard Clinical Practice during Routine General Anaesthesia on post-operative pain scores and post-operative opioid requirement in patients undergoing spinal surgery

The University of Adelaide0 sites60 target enrollmentFebruary 11, 2014

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
The University of Adelaide
Enrollment
60
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 11, 2014
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for non\-emergent, spinal surgery, aged 18\-75 years, American Society of Anesthesiologists (ASA) score 1 or 2, competent to consent to participation, able to use a Visual Analogue Scale (VAS) and able to activate a patient controlled analgesia (PCA) machine post\-operatively.

Exclusion Criteria

  • Emergency surgery
  • Inability to consent, lack of written consent or speak English fluently
  • Pregnancy or lactation. Pregnancy test will be performed in all women of child bearing potential
  • Cardiac morbidity
  • Non\-regular sinus cardiac rhythym
  • Cardiac disease which impacts usual daily functioning (equivalent to ASA greater than or equal to 3\)
  • Implanted cardiac pacemaker
  • Concurrent medications with a major effect affect upon the sinus node
  • Expected duration of surgery greater than 3 hours (180 minutes)
  • Extremes of weight (Body Mass Index less than or equal to 19 or greater than or equal to 35 kg per meter squared)

Outcomes

Primary Outcomes

Not specified

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