CompletedPhase 2ACTRN12614000169640

Comparison of Analgesia Nociception Index (ANI) guided analgesia administration with Standard Clinical Practice during Routine General Anaesthesia

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

Sponsor

The University of Adelaide

Enrollment

60 participants

Start Date

Feb 12, 2014

Study Type

Interventional

Conditions

Acute Pain

Summary

The proposed study aims to evaluate Analgesia Nociception Index (ANI) titrated analgesia in patients undergoing spinal surgery. This clinical utility study is designed to investigate the effect of ANI guided fentanyl administration on post-operative events, including self-reported post-operative pain scores, analgesia administration, recovery times, and opioid-related side effects. The study will also record the incidence of unwanted intra-operative events such as tachycardia, hypertension, and the consumption of fentanyl under constant hypnotic level balanced general anaesthesia.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Inclusion Criteria1

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 Criteria13

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)
Pre-operative chronic opioid use or chronic pain, equivalent to oxycodone 20mg per oral, per day for more than 6 weeks
Allergy or intolerance to any of the study drugs
Use of neuraxial anaesthesia

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Interventions

The proposed study aims to evaluate Analgesia Nociception Index (ANI) titrated analgesia in patients undergoing spinal surgery. The ANI Monitor examines small fluctuations in heart rate to determine

The proposed study aims to evaluate Analgesia Nociception Index (ANI) titrated analgesia in patients undergoing spinal surgery. The ANI Monitor examines small fluctuations in heart rate to determine the level of analgesia to nociception balance. This clinical utility study is designed to investigate the effect of ANI monitor guided fentanyl administration on post-operative events, including self-reported post-operative pain scores, analgesia administration, recovery times, and opioid-related side effects. The monitor will be applied prior to induction of anaesthesia and removed once the patient is ready for transfer to a general nursing ward. The study will also record the incidence of unwanted intra-operative events such as tachycardia, hypertension, and the consumption of fentanyl under constant hypnotic level balanced general anaesthesia.