Opioid-free Anesthesia and Acute Postoperative Pain

NCT04976842 | Unknown

• 1 other identifier: OFA 1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Anesthesia; Postoperative Pain; Cognitive Impairment, Variable

Keywords

ANESTHESIA; OPIOIDS; PAIN; COGNITIVE

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  Intensity of acute postoperative pain (measured by numeric rating scale NRS 0-10), time frame up to 24h postoperatively

  baseline and 24 hours

Secondary Outcomes (1)

• postoperative cognitive dysfunction

  baseline and 24 hours

Study Arms (2)

Opioid-free anesthesia

ACTIVE COMPARATOR

Opioid free anesthesia protocol for urological procedurs

Device: OFA

Opioid-based anesthesia

ACTIVE COMPARATOR

Opioid based anesthesia protocol for urological procedures

Drug: OBA

Interventions

OFA DEVICE

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.

Opioid-free anesthesia

OBA DRUG

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).

Opioid-based anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged\>18 years old
• ASA I-III
• Patients scheduled for elective transurethral urologic surgery with general anesthesia

You may not qualify if:

• 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)

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.

Athens, 12462, Greece

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Cognitive Dysfunction; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

CHRΥSANTHI BATISTAKI, MD, PHD

CONTACT

00302105832371; chrysabatistaki@yahoo.gr

Paraskevi Matsota, MD, PHD

CONTACT

00302105832371; matsota@yahoo.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the investigator assessing outcome did not know the kind of anesthesia the patient received
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesiology

Model Details: 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

Study Record Dates

• First Submitted: July 10, 2021
• First Posted: July 26, 2021
• Study Start: August 1, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 13, 2021

Record last verified: 2021-08

Locations

GR (1)