Opioid-free Anesthesia and Acute Postoperative Pain
Primary Purpose
Anesthesia, Postoperative Pain, Cognitive Impairment, Variable
Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
OFA
OBA
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia focused on measuring ANESTHESIA, OPIOIDS, PAIN, COGNITIVE
Eligibility Criteria
Inclusion Criteria:
- Patients aged>18 years old
- ASA I-III
- Patients scheduled for elective transurethral urologic surgery with general anesthesia
Exclusion Criteria:
• Patient refusal
- Use of opioids pre-op
- Inability to read or write
- Known psychiatric disease under medication
- Dementia
- Severe liver and renal disease
- Known allergy to drugs used
- Known arrhythmia (2nd-3rd AV block, acute unstable angina, acute myocardial infarction in the past 6 weeks or severe cardiac problem-condition)
- Heart rate<45 bpm
- Pre-op minimental test<23
- Major surgery complications (hemorrhage with need for transfusion)
Sites / Locations
- 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Opioid-free anesthesia
Opioid-based anesthesia
Arm Description
Opioid free anesthesia protocol for urological procedurs
Opioid based anesthesia protocol for urological procedures
Outcomes
Primary Outcome Measures
postoperative pain
Intensity of acute postoperative pain (measured by numeric rating scale NRS 0-10), time frame up to 24h postoperatively
Secondary Outcome Measures
postoperative cognitive dysfunction
Change in minimental state evaluation test up to 24 hours postoperatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04976842
Brief Title
Opioid-free Anesthesia and Acute Postoperative Pain
Official Title
Acute Postoperative Pain in Opioid-free Anesthesia After Urological Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attikon Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Control of intraoperative and postoperative pain with the use of opioids constitutes normal practice. Opioid free anesthesia (OFA) is a relatively recent anesthesiology practice according to which opioids are not administered during surgery and are avoided postoperatively. Opioid free anesthesia seems to provide better quality of postoperative analgesia while protecting the patient from the side effects of opioids such as respiratory depression, postoperative nausea and vomiting (PONV), opioid induced hyperalgesia and postoperative cognitive dysfunction. The aim of this study is to investigate the possible difference in the intensity of postoperative pain (based on the numeric rating scale 0-10) and the presence of PONV in patients undergoing transurethral urologic surgery under general anesthesia, when patients receive randomly either opioid free anesthesia (OFA) or opioid based anesthesia (OBA).
Detailed Description
This study aimed to study postoperative pain after opioid free anesthesia or opioid based anesthesia after urologica; procedures. The two study groups opioid free (OFA) and opioid based (OBA) were as follows:
OFA: Anesthesiology technique based on Mulier protocol. Before induction, loading dose of dexmedetomidine 0,25mcg/kg (max 20mcg). Induction with dexmedetomidine 0,1mcg/kg, lidocaine 1mg/kg, ketamine 0,1mg/kg plus propofol 2mg/kg plus rocuronium1mg/kg IBW (if required). Maintenance with dexmedetomidine 0,1mcg/kg/h, lidocaine 1mg/kg/h, ketamine 0,1mg/kg/h and propofol infusion adjusted according to bispectral index indication ( BIS maintained 40-60). 15 minutes prior to end of surgery, the dose of drugs is reduced to dexmedetomidine 0,05mcg/kg/h, lidocaine 0,5mg/kg/h, ketamine 0,05mg/kg/h.
OBA: Total intravenous anesthesia with propofol for maintenance of anesthesia. Fentanyl 2mcg/kg only at induction and infusion of propofol and remifentanil for maintenance, with doses adjusted according to bispectral index indication ( BIS maintained 40-60).
Both groups receive ranitidine 50mg, dexamethasone 4 mg and paracetamol 1g iv 15 min before the end of surgery. Postoperative analgesia for both groups consists of paracetamol 3g/24h iv, rescue analgesia with tramadol 1mg/kg iv max x3, rescue for PONV ondacetron 4 mg iv.
The outcomes assessed were:
Primary outcome:
Intensity of acute postoperative pain (NRS 0-10), time frame up to 24h postoperatively
Nausea and vomiting
Secondary outcome:
Change in minimental state evaluation test, time frame pre-op, 1h post-op, at discharge
Severe postoperative adverse effect related to anesthesia (postoperative hypoxemia, ileus, postoperative cognitive dysfunction)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Postoperative Pain, Cognitive Impairment, Variable
Keywords
ANESTHESIA, OPIOIDS, PAIN, COGNITIVE
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups of patients assigned to either opioid-free anesthesia or opioid-based anesthesia were studied in a randomized manner as for postoperative pain and cognitive dysfunction
Masking
ParticipantOutcomes Assessor
Masking Description
the investigator assessing outcome did not know the kind of anesthesia the patient received
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Opioid-free anesthesia
Arm Type
Active Comparator
Arm Description
Opioid free anesthesia protocol for urological procedurs
Arm Title
Opioid-based anesthesia
Arm Type
Active Comparator
Arm Description
Opioid based anesthesia protocol for urological procedures
Intervention Type
Device
Intervention Name(s)
OFA
Intervention Description
Anesthesiology technique based on Mulier protocol. Before induction, loading dose of dexmedetomidine 0,25mcg/kg (max 20mcg). Induction with dexmedetomidine 0,1mcg/kg, lidocaine 1mg/kg, ketamine 0,1mg/kg plus propofol 2mg/kg plus rocuronium1mg/kg IBW (if required). Maintenance with dexmedetomidine 0,1mcg/kg/h, lidocaine 1mg/kg/h, ketamine 0,1mg/kg/h and propofol infusion adjusted according to bispectral index indication ( BIS maintained 40-60). 15 minutes prior to end of surgery, the dose of drugs is reduced to dexmedetomidine 0,05mcg/kg/h, lidocaine 0,5mg/kg/h, ketamine 0,05mg/kg/h.
Intervention Type
Drug
Intervention Name(s)
OBA
Intervention Description
Total intravenous anesthesia with propofol for maintenance of anesthesia. Fentanyl 2mcg/kg only at induction and infusion of propofol and remifentanil for maintenance, with doses adjusted according to bispectral index indication ( BIS maintained 40-60).
Primary Outcome Measure Information:
Title
postoperative pain
Description
Intensity of acute postoperative pain (measured by numeric rating scale NRS 0-10), time frame up to 24h postoperatively
Time Frame
baseline and 24 hours
Secondary Outcome Measure Information:
Title
postoperative cognitive dysfunction
Description
Change in minimental state evaluation test up to 24 hours postoperatively
Time Frame
baseline and 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged>18 years old
ASA I-III
Patients scheduled for elective transurethral urologic surgery with general anesthesia
Exclusion Criteria:
• Patient refusal
Use of opioids pre-op
Inability to read or write
Known psychiatric disease under medication
Dementia
Severe liver and renal disease
Known allergy to drugs used
Known arrhythmia (2nd-3rd AV block, acute unstable angina, acute myocardial infarction in the past 6 weeks or severe cardiac problem-condition)
Heart rate<45 bpm
Pre-op minimental test<23
Major surgery complications (hemorrhage with need for transfusion)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CHRΥSANTHI BATISTAKI, MD, PHD
Phone
00302105832371
Email
chrysabatistaki@yahoo.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Paraskevi Matsota, MD, PHD
Phone
00302105832371
Email
matsota@yahoo.gr
Facility Information:
Facility Name
2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chrysanthi Batistaki, MD, PhD
Phone
0030 210 5832371
Email
chrysabatistaki@yahoo.gr
12. IPD Sharing Statement
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Opioid-free Anesthesia and Acute Postoperative Pain
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