A Comparative Study of Intraoperative Fentanyl Consumption Guided by Analgesia Nociception Index Versus Standard Protocol in Patients Undergoing Mastectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Pain
- Sponsor
- Khon Kaen University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Postoperative pain: NRS
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Balanced anesthesia needs optimization of hypnotic, relaxant, and narcotic. Administration of hypnotic drugs can be monitored by bispectral index score (BIS), while the dosage of muscle relaxants can be guided by train-of four (TOF). However, administration of narcotics lacks objective monitor. Overdosage of narcotic may lead to delayed awakening, while underdosage may lead to high degree of postoperative pain. Recently, there is a monitor, Analgesic Nociceptive Index (ANI) monitor, designed to guide the administration of narcotics. There are many descriptive studies supporting the correlation of ANI score and pain score but there are still very few randomized control studies which report the efficacy of ANI in clinical practice.
Detailed Description
Objective: To evaluate the efficacy of ANI to guide the administration of intraoperative fentanyl. Methods: Sixty female patients undergoing breast surgery with balanced anesthesia will be randomized into 2 groups. The first group will receive fentanyl according to standard practice of attending anesthesiologists. The second group will receive fentanyl according to ANI score protocol. Primary outcome: Postoperative pain numeric rating scale (NRS) score during 60 minutes in postanesthetic care unit (PACU). Secondary outcomes: Total intraoperative dose of fentanyl and postoperative nausea/vomiting and sedation score in PACU.
Investigators
Thepakorn Sathitkarnmanee
Associate professor
Khon Kaen University
Eligibility Criteria
Inclusion Criteria
- •Adults female undergoing elective breast surgery
- •American Society of Anesthesiologists (ASA) classification I-III
- •Body mass index (BMI) 18.5-35 kg/m2
Exclusion Criteria
- •Implanted pacemaker
- •Cardiac arrythmia
- •Autonomic nervous system (ANS) disorder, e.g. epilepsy, stroke
- •Chronic opioid use
- •Chronic pain
- •On beta-blocker, calcium channel blocker, or other drugs to control arrythmia
- •Previous mastectomy
- •Pregnancy
- •On Nsaids
Outcomes
Primary Outcomes
Postoperative pain: NRS
Time Frame: during 60 minutes in PACU
Measure pain numeric rating scale (NRS) every 15 minutes. NRS has a range from 0 to 10 with 0 indicates no pain while 10 indicates worst pain. NRS of 0-3 is mild, 4-6 is moderate, and 7-10 is severe pain.
Secondary Outcomes
- Intraoperative fentanyl consumption(During intraoperative period)
- Intraoperative ANI score(During intraoperative period)
- Postoperative nausea/vomiting(During 24 hours postoperatively)
- Postoperative sedation score(During 24 hours postoperatively)