NCT03417193

Brief Summary

This study compares the intraoperative opioid free anesthesia approach in multilevel spine posterior instrumentation surgery to a conventional opioid-based anesthesia. Half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

January 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

5.1 years

First QC Date

January 16, 2018

Last Update Submit

February 16, 2023

Conditions

Opioid UsePostoperative PainSpine Disease

Keywords

LidocaineDexmedetomidineOpioid-free

Outcome Measures

Primary Outcomes (1)

  • Postoperative morphine consumption

    After the surgery the patient will go to the PACU (Post Anesthesia Care Unit). the patient will receive morphine if the pain score is more than 4. the total dose of morphine in mg (milligrams) will be documented. Before discharge from the PACU, the patient will have a PCA (Patient Controlled Analgesia) morphine,All attempts and given values of morphine In mg obtained from the PCA machine will be documented at 0, 1, 2, 4, 6, 12, 18, and 24 hours and every 6 hours thereafter up to 48 hours post surgery.. And the total amount of morphine in mg will be calculated for 48 hours

    48 hours

Secondary Outcomes (5)

  • Postoperative morphine Side effects: Sedation score .

    48 hours post operative.

  • Postoperative morphine Side effects:Respiratory depression

    48 hours

  • Postoperative morphine Side effects: Nausea vomiting

    48 hours

  • Postoperative morphine Side effects: Itching

    48 hours

  • Postoperative pain score

    48 hours post operative.

Study Arms (2)

Opioid based Anesthesia

ACTIVE COMPARATOR

General anesthesia will be induced using Propofol , fentanyl , and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with Remi-fentanyl , sevoflurane and nitrous oxide.

Drug: opioid free Anesthesia vs Opioid based Anesthesia

Opioid Free Anesthesia

ACTIVE COMPARATOR

-General anesthesia will be induced using dexmedetomidine and lidocaine started 10 minutes before induction, Propofol and Rocuronium . Ketamine will be administered on induction of anesthesia with the same dose to be repeated every hour. Anesthesia will be maintained with IV infusion of dexmedetomidine , lidocaine , sevoflurane and nitrous oxide.

Drug: opioid free Anesthesia vs Opioid based Anesthesia

Interventions

opioid free Anesthesia vs Opioid based AnesthesiaDRUG

Compare the opioid based anesthesia with Fentanyl and Remifentanyl to opioid free anesthesia with dexmedetomidine and lidocaine and their effect on postoperative pain.

Opioid Free AnesthesiaOpioid based Anesthesia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age group: 18-80 years old
  • American Society of Anesthesiologists (ASA )class I, II and III
  • Elective spine posterior instrumentation surgery of at least two levels.

You may not qualify if:

  • Renal, hepatic or cardiac insufficiency.
  • Alcohol or drug abuse.
  • Psychiatric disease.
  • Allergy or contraindication to any of the study drugs.
  • Inability to comprehend pain assessment or inability to use a Patient Controlled Analgesia (PCA) device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAU Medical Center

Beirut, Lebanon

Location

MeSH Terms

Conditions

Pain, PostoperativeSpinal Diseases

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsBone DiseasesMusculoskeletal Diseases

Study Officials

  • Hanane MD

    Lebanese American University/ LAU Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 16, 2018

First Posted

January 31, 2018

Study Start

January 29, 2018

Primary Completion

February 16, 2023

Study Completion

February 16, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)