RecruitingPhase 4ACTRN12612001075875

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


Sponsor

fremantle Hospital

Enrollment

44 participants

Start Date

Sep 17, 2012

Study Type

Interventional

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at how a medication called clonidine affects a new type of anaesthetic monitor called the Analgesia Nociception Index (ANI). The ANI monitor uses changes in heart rate patterns to estimate how much pain a patient is feeling during surgery. Clonidine is a non-opioid pain reliever and sedative. Researchers want to know if clonidine changes the ANI readings in a way that could affect how anaesthesiologists use this monitor during keyhole gallbladder removal surgery. You may be eligible if: - You are 18 years or older - You are scheduled for laparoscopic cholecystectomy (keyhole surgery to remove the gallbladder) You may NOT be eligible if: - You are unable to give consent - You are under 18 years old - You have a pre-existing heart rhythm problem (arrhythmia) - You have an allergy or sensitivity to clonidine - You have diabetes with nerve damage (autonomic neuropathy) - You have sepsis or unstable blood pressure - You have chronic pain Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 als

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


Locations(1)

Australia

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ACTRN12612001075875