ANI-guided Intraoperative Analgesia in Low-pressure Anesthesia
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|ClinicalTrials.gov Identifier: NCT04319913|
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Analgesia Functional Endoscopic Sinus Surgery Heart Rate Variability Opioid Consumption||Device: analgesia nociception index||Not Applicable|
Analgesia nociception index (ANI) is an objective pain monitoring device, it could measure parasympathetic tone base on heart rate variability analysis, which is a way to measure the effect of respiratory sinus arrhythmia on heart rate. In the previous studies, ANI had been used to predict immediate postoperative pain, intraoperative analgesia in children, and intraoperative analgesia in bariatric surgery, which showed ANI can be used to detect surgical stimuli, reduce intraoperative consumption of narcotics, and assess immediate postoperative pain intensity. However, no publication has mentioned ANI been used in low-pressure anesthesia.
Participants with ASA physical status class I or II, age between 20-65, and body mass index less than 35 who would undergo FESS are enrolled and randomly allocated by using computer-generated random number table into two groups with equal probability: ANI-guided remifentanil titration or remifentanil titration by standard care. Total intravenous anesthesia with propofol TCI(target controlled infusion) and remifentanil TCI are used for anesthesia maintenance, targeting bispectral index between 40 and 60. The ANI value in experimental group would be maintained between 50 and 70. Intraoperative mean arterial pressure (MAP) would be targeted at 55-65 mmHg, and calcium channel blocker would be administered if MAP could not achieve target despite of propofol and remifentanil titration.
Participant's demographics, baseline information, type and duration of the operation, duration from end of the surgery till participant awaken, ANI value, vital signs, the amount of narcotics, anesthetics and antihypertensive medications used, intraoperative blood loss, surgeon's satisfaction to the operation field, participant first recorded pain score in postoperative recovery room using visual analogue scale, and opioid-associated side effects such as nausea, vomiting, pruritis, dizziness in postoperative recovery room, will be recorded and analyzed. The statisticians will apply Chi-square for categorical data, T-test for continuous data, and multiple regressions analysis. P value less than 0.05 was considered statistically significant. Using G-power software to estimate, predicted sample size is 120 presuming type I error 0.05, power 0.95, and medium effect size.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||The analgesia nociception index sensors are a pair of patches. They would be placed on the participant's right shoulder and the left side of the chest before the induction of general anesthesia, recording the ANI value throughout the operation. In the control group, the ANI monitor would be covered up, so that the care provider could only titrate remifentanil based on clinical experience. The participants would be masked from which group they were allocated into. The surgeon would be masked from the participant's allocation, and surgeon's satisfaction to the operation field would be surveyed by a questionnaire right after the operation, also the estimated blood loss amount would be recorded by the same surgeon.|
|Official Title:||Whether Intraoperative Analgesia Guided by the Analgesia Nociception Index (ANI) Can Decrease the Amount of Narcotics, Other Anesthetic Drugs, and Blood Loss in Patients Undergoing Low-pressure Anesthesia: a Randomized Controlled Trial|
|Estimated Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||July 1, 2023|
ANI-guided narcotics use to maintain ANI value between 50 to 70
Device: analgesia nociception index
Analgesia nociception index (ANI) could objectively monitor how pain the participant is. In the experimental group, the care provider would decrease the dose of narcotics (remifentanil) if the ANI value is above 70, and increase the dose if the ANI value is under 50.
No Intervention: Control
narcotics use guided by clinical experience, ANI is still recorded but would be covered up intraoperatively
- Narcotics consumption [ Time Frame: From the first given dose of remifentanil until the last given given dose of remifentanil during anesthesia, assessed up to 8 hours. ]Remifentanil would be used as narcotics, the total amount used intraoperatively would be recorded
- Anesthetics consumption [ Time Frame: From the first given dose of anesthetics (propofol or midazolam, whichever comes first) until the last given given dose of anesthetics (propofol or midazolam, whichever comes last), assessed up to 8 hours. ]The amount of anesthetics (mainly propofol) used intraoperatively would be recorded
- Blood loss [ Time Frame: the estimated blood loss would be recorded immediately after the operation ]Blood loss would be estimated by surgeon
- Bleeding of the operation field [ Time Frame: The questionnaire would be provided to the surgeon immediately after the operation ]
Bleeding of the operation field would be surveyed to surgeons by a questionnaire.
The clarity of operation field:
- Minimal bleeding: no need of suction.
- Slightly bleeding: suction sometimes.
- Moderate bleeding: Suction frequently
- Severe bleeding: surgical field compromised even right after suction
- Continuous bleeding.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319913
|Contact: Chien-Chung Huang, MD||+886225433535 ext email@example.com|
|MacKay Memorial Hospital|
|Taipei, Taiwan, 104|
|Study Director:||Chien-Chung Huang, MD||Mackay Memorial Hospital|