- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05147714
The Relationship Of The Surgical Pleth Index Values With Postoperative Pain Score And Analgesia Consumption
The Relationship on The Surgical Pleth Index Values Observed at The End of The Surgical Procedure With Postoperative Pain Score and Analgesia Consumption
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After arrival in the operating room, patients were monitored with electrocardiogram (ECG), non-invasive arterial pressure measurement, pulse oximetry, neuromuscular monitoring (GE Datex, Ohmeda TOF module), entropy (GE Datex, Ohmeda Entropy Module) and SPI. Intravenous midazolam (0.03-0.05 mg/kg), fentanyl (1mcg/kg) were used before induction of anaesthesia. For anesthetic induction, propofol was administered until the entropy value fell below 60, followed by rocuronium was performed intravenous 0.6mg/kg. Patients were intubated with endotracheal tube than the mechanical ventilation was initiated with a mixture of O2 and air with FiO2 0.5 and adjusted to maintain end-tidal CO2 pressure of 35 and 40 mmHg. Intravenous propofol and remifentanil infusion were used for anesthesia maintenance and entropy was maintained below 60. Furthermore, SPI was maintained below 50.
Tenoxicam 20 mg, paracetamol 1 g and 0.5 mg/kg tramadol intravenously were administered 30 minutes before the end of the surgery to each patient who had no contraindications. After the last suture, the anesthetic agents were stopped and was considered the end of the surgery. Then SPI data were recorded at one-minute intervals during the last five minutes (6 times in total) until the entropy value reached 60. Patients who has cooperation were extubated and taken to the recovery room. The first time that the patients cooperated in the recovery room was considered as the zeroth minute. During the postoperative observation, the patient's pain score was questioned using the Numeric Rating Scale (NRS) every five minutes. If NRS≥4, intravenous tramadol 10 mg (100 mg as the maximum dose) was administered to the patient. The patient was followed in the recovery room for 30 minutes and until NRS <4. However, if NRS≥4 was still present at the end of the observation period, an additional 2 mg dose of morphine was administered. The maximum dose of morphine was determined as 0.1mg/kg.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34093
- Istanbul University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 18 to 65 years
- ASA physical status I-III
- Who received craniotomy and intracranial mass excision
Exclusion Criteria:
- Diagnosed diabetic neuropathy
- Using pacemaker
- Needing vasoactive agent during the observation
- Using ketamine
- Using agents such as beta-blockers, beta-agonists, sympatholytic agents, atropine, neostigmine that will affect the sympatho-vagal balance during the observation period
- The patients who could not provide sufficient cooperation for scoring were not included in the study.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Postoperative Pain
Time Frame: Postoperative 30 minutes
|
During the postoperative observation, the patient's pain score was questioned using the Numeric Rating Scale (NRS)
|
Postoperative 30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mukadder Orhan Sungur, Prof., Istanbul University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/936
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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