Opioid-free Anesthesia With a Mixture of Dexmedetomidine-lidocaine-ketamine

NCT04858711 | Unknown

• 1 other identifier: 306/26-03-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus fentanyl analgesia in elective laparoscopic gynecological surgery

Conditions

Pain, Postoperative; Pain, Acute; Pain, Chronic; Pain, Neuropathic; Pain, Nociceptive; Ketamine; Dexmedetomidine; Lidocaine; Central Nervous System Depressants; Analgesia; Analgesics; Analgesics Non-narcotic

Outcome Measures

Primary Outcomes (6)

• change from baseline in Quality of Recovery (QoR)-15 score after surgery

  The QoR-15 is a quality of recovery scale that consists of 15 questions (items),including questions regarding pain (2 items), physical comfort (5 items), self-care ability (2 items), psychological support (2 items) and emotional state (4 items). Every item is scored on a scale of 10, with the lowest total score of 0 and the highest score of 150. The higher the score, the better the recovery quality of the patient

  24 hours postoperatively

• pain score on arrival to Post-Anesthesia Care Unit (PACU)

  pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  immediately postoperatively

• pain score at discharge from Post-Anesthesia Care Unit (PACU)

  pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively

• pain score 3 hours postoperatively

  pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  3 hours postoperatively

• pain score 6 hours postoperatively

  pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  6 hours postoperatively

• pain score 24 hours postoperatively

  pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

  24 hours postoperatively

Secondary Outcomes (19)

• Post Anesthesia Care Unit (PACU) duration of stay

  immediately postoperatively

• sedation on arrival to Post-Anesthesia Care Unit

  immediately postoperatively

• sedation at discharge from Post-Anesthesia Care (PACU) Unit

  at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively

• sevoflurane consumption during general anesthesia

  change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 2-3 hours

• time to first request for analgesia

  during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively

Other Outcomes (2)

• time to emergence

  up to 2-3 hours after start of surgery

• time to extubation

  up to 2-3 hours after start of surgery

Study Arms (2)

ketamine-lidocaine-dexmedetomidine (KLD) group

ACTIVE COMPARATOR

combination of ketamine-lidocaine-dexmedetomidine in one syringe

Drug: ketamine-lidocaine-dexmedetomidine

fentanyl (control) group

ACTIVE COMPARATOR

syringe of fentanyl

Drug: fentanyl

Interventions

ketamine-lidocaine-dexmedetomidine DRUG

In the KLD group, patients will be administered 0,25 mcg/kg Dexmedetomidine in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations. As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution.

Also known as: KLD group

ketamine-lidocaine-dexmedetomidine (KLD) group

fentanyl DRUG

In the fentanyl group, patients will be administered 2 mcg/kg fentanyl in 100 mL of normal saline within 10 minutes. Followingly, they will receive 1mL/10 kg of normal saline solution 0.9%. As maintenance, they will be receiving 1mL/10kg/h of normal saline solution 0.9%.

Also known as: Control group

fentanyl (control) group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult female patients
• American Society of Anesthesiologists (ASA) classification I-II
• elective laparoscopic gynecological surgery

You may not qualify if:

• body mass index (BMI) \>35 kg/m2
• contraindications to local anesthetic administration or non-steroidal agents administration
• systematic use of analgesic agents preoperatively
• chronic pain syndromes preoperatively
• neurological or psychiatric disease on treatment
• pregnancy
• severe hepatic or renal disease
• history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
• bradycardia(\<55 beats/minute)
• drug or alcohol abuse
• language or communication barriers lack of informed consent

Sponsors & Collaborators

• Aretaieion University Hospital: lead

Study Sites (1)

Aretaieion University Hospital

Athens, 115 28, Greece

RECRUITING

Related Publications (9)

• Lavand'homme P, Steyaert A. Opioid-free anesthesia opioid side effects: Tolerance and hyperalgesia. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):487-498. doi: 10.1016/j.bpa.2017.05.003. Epub 2017 May 17.

  PMID: 29739537 BACKGROUND

• Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.

  PMID: 30802933 BACKGROUND

• Lavand'homme P, Estebe JP. Opioid-free anesthesia: a different regard to anesthesia practice. Curr Opin Anaesthesiol. 2018 Oct;31(5):556-561. doi: 10.1097/ACO.0000000000000632.

  PMID: 29994942 BACKGROUND

• Mulier J. Opioid free general anesthesia: A paradigm shift? Rev Esp Anestesiol Reanim. 2017 Oct;64(8):427-430. doi: 10.1016/j.redar.2017.03.004. Epub 2017 Apr 18. No abstract available. English, Spanish.

  PMID: 28431750 BACKGROUND

• Mauermann E, Ruppen W, Bandschapp O. Different protocols used today to achieve total opioid-free general anesthesia without locoregional blocks. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):533-545. doi: 10.1016/j.bpa.2017.11.003. Epub 2017 Nov 24.

  PMID: 29739542 BACKGROUND

• Panchgar V, Shetti AN, Sunitha HB, Dhulkhed VK, Nadkarni AV. The Effectiveness of Intravenous Dexmedetomidine on Perioperative Hemodynamics, Analgesic Requirement, and Side Effects Profile in Patients Undergoing Laparoscopic Surgery Under General Anesthesia. Anesth Essays Res. 2017 Jan-Mar;11(1):72-77. doi: 10.4103/0259-1162.200232.

  PMID: 28298760 BACKGROUND

• Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.

  PMID: 21061107 BACKGROUND

• De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.

  PMID: 23669270 BACKGROUND

• Mulier JP. Is opioid-free general anesthesia for breast and gynecological surgery a viable option? Curr Opin Anaesthesiol. 2019 Jun;32(3):257-262. doi: 10.1097/ACO.0000000000000716.

  PMID: 31045633 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Chronic Pain; Neuralgia; Nociceptive Pain; Agnosia

Interventions

Fentanyl; Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Kassiani Theodoraki, phD, DESA

  Aretaieion University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kassiani Theodoraki, PhD, DESA

CONTACT

+306974634162; ktheodoraki@hotmail.com

Sofia Apostolidou, MD

CONTACT

sofia.apos@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 26, 2021
• Study Start: April 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)