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

NCT04858711 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-10-24

No results posted yet for this study

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

Interventions

DRUG

ketamine-lidocaine-dexmedetomidine

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.

DRUG

fentanyl

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%.

Sponsors & Collaborators

  • Aretaieion University Hospital

    lead OTHER

Principal Investigators

  • Kassiani Theodoraki, phD, DESA · Aretaieion University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Greece

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04858711 on ClinicalTrials.gov