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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000169640

Enrollment

Registered

2014-02-11

Start date

2014-02-12

Completion date

2015-03-13

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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) 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

Outcome results