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The effect of clonidine on heart rate variability analysis in patients undergoing key-hole surgery to remove gallbladder

A prospective study to validate the effect of clonidine on Analgesia Nociceptive Index in patients undergoing laparoscopic cholecystectomy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001075875
Enrollment
44
Registered
2012-10-08
Start date
2012-09-17
Completion date
Unknown
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

Clonidine has been effectively used as a non-opioid (morphine-like) pain killer and sedative in a variety of clinical settings for many years. The Analgesia Nociceptive Index (ANI) monitor is a novel anaesthetic monitor that has been developed for use with opioid based pain killers. It works by assessing (primarily) heart rate variability to generate a score which gives an indication of nociceptive (painful) inputs. This study aims to examine the effects of clonidine on the ANI under general anaesthesia for laparoscopic cholecystectomy, as part of the pain relieving strategy

Interventions

Patients will receive a standardised protocol for induction of anaesthesia with fentanyl, propofol and rocuronium. . A standard IV paracetamol 1g and IV Parecoxib 40mg (if no contraindication) are also given. Analgesia Nociception Index (ANI) will be recorded at every 5 minute intervals. IV Clonidine 1mcg/kg will be given 5 mins following pneumoperitoneum. Any further dose of fentanyl given will be recorded

Sponsors

fremantle Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Laparoscopic cholecystectomy

Exclusion criteria

unable to consent below 18 years old Established arrhythmias Allergy/sensitivity to clonidine diabetes mellitus and autonomic neuropathy sepsis/ emodynamic instability chronic pain

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026