Opioid-free Anesthesia and Acute Postoperative Pain

NCT ID: NCT04976842

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2022-08-01

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:

1. Intensity of acute postoperative pain (NRS 0-10), time frame up to 24h postoperatively

2. Nausea and vomiting

Secondary outcome:

1. Change in minimental state evaluation test, time frame pre-op, 1h post-op, at discharge

2. Severe postoperative adverse effect related to anesthesia (postoperative hypoxemia, ileus, postoperative cognitive dysfunction)

Conditions

Anesthesia; Postoperative Pain; Cognitive Impairment, Variable

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Opioid-free anesthesia

Opioid free anesthesia protocol for urological procedurs

Group Type: ACTIVE_COMPARATOR

OFA

Intervention Type: 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-based anesthesia

Opioid based anesthesia protocol for urological procedures

Group Type: ACTIVE_COMPARATOR

OBA

Intervention Type: 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).

Interventions

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.

Intervention Type: DEVICE

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).

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Attikon Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chrysanthi Batistaki

Associate Professor of Anaesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

CHRΥSANTHI BATISTAKI, MD, PHD

Role: CONTACT

chrysabatistaki@yahoo.gr

00302105832371

Paraskevi Matsota, MD, PHD

Role: CONTACT

matsota@yahoo.gr

00302105832371

Facility Contacts

Chrysanthi Batistaki, MD, PhD

Role: primary

chrysabatistaki@yahoo.gr

0030 210 5832371

Other Identifiers

OFA 1

Identifier Type: -

Identifier Source: org_study_id