Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Analgesic Effectiveness of Intravenous Ketamine and Fentanyl for Spinal Anesthesia is Sitting Position in Patients With Proximal Femur Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04418674
Recruitment Status : Unknown
Verified June 2020 by Jenny Bajracharya, B.P. Koirala Institute of Health Sciences.
Recruitment status was:  Recruiting
First Posted : June 5, 2020
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Jenny Bajracharya, B.P. Koirala Institute of Health Sciences

Brief Summary:

This is a prospective comparative study which will be conducted in patients with proximal femur fracture undergoing operative interventions under subarachnoid block in sitting position. Ketamine group will receive 0.3mg/kg intravenously and Fentanyl group will receive 1.5mcg/kg before changing the position from supine to sitting for subarachnoid block. Analgesic effectiveness of the two drugs will be compared by Numeric Rating Scale for pain.

Research hypothesis (Null hypothesis) There is no difference in analgesic effectiveness, patient satisfaction, spinal performance and occurrence of adverse effects between Intravenous ketamine and intravenous fentanyl in patients with proximal femur fracture.

Alternate hypothesis Intravenous Ketamine in patients with proximal femur fracture improves the level of analgesia, patient satisfaction, spinal performance and occurrence of adverse effects when compared to intravenous fentanyl.


Condition or disease Intervention/treatment Phase
Fracture of Proximal End of Femur Drug: Ketamine Drug: Fentanyl Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Ketamine Group: Ketamine 0.3mg/kg intavenously before changing the position from supine to sitting for subarachnoid block.

Fentanyl group: Fentanyl 1.5mcg/kg intravenously before changing the position from supine to sitting position for subarachnoid block.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

0.4ml from one 1 ml ampule of 50mg ketamine will be diluted with 9.6ml NS to make a concentration of 2mg Ketamine in each ml in a 10 ml syringe.

One 2ml ampule of 100mcg Fentanyl will be diluted with 8 ml NS to make a concentration of 10mcg in each ml in a 10ml syringe

Ketamine and Fentanyl will be administered as clear fluid from a 10ml syringe labelled as Study drug, therefore, both the patient and investigator will be blinded.

Primary Purpose: Treatment
Official Title: Comparison of Analgesic Effectiveness of Intravenous Ketamine and Fentanyl for Spinal Anesthesia is Sitting Position in Patients With Proximal Femur Fracture
Actual Study Start Date : June 25, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ketamine
Patient will be given Ketamine 0.3mg/kg intravenously before sitting positioning for subarachnoid block.
Drug: Ketamine
in this group, patient will receive ketamine at 0.3mg/kg intravenously.

Active Comparator: Fentanyl
Patient will be given Fentanyl 1.5mcg/kg intravenously before sitting position for subarachnoid block.
Drug: Fentanyl
In this group, the patients will receive fentanyl at 1.5mcg/kg intavenously.




Primary Outcome Measures :
  1. Numeric Rating Scale for Pain [ Time Frame: 1 to 20 minutes ]
    Level of analgesia for subarachnoid block in sitting position measured by Numeric Rating Rating Scale for pain. Scale ranges from 0 to 10, where 0 is no pain and 10 being maximum/ worst imaginable pain.


Secondary Outcome Measures :
  1. Likert Satisfaction score [ Time Frame: 1 to 20 minutes ]
    Patient satisfaction for positioning the patient for subarachnoid block using Likert score will be used. It ranges from 1 to 5 (1=strongly dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=strongly satisfied)

  2. Anesthetist Satisfaction Score [ Time Frame: 1 to 20 minutes ]
    Anesthetist satisfaction for positioning the patient for subarachnoid block as good, satisfactory and Optimal

  3. Number of attempts for successful spinal needle placement [ Time Frame: 1 to 20 minutes (While performing subarachnoid block) ]
    Number of attempts for successful spinal needle placement

  4. Adverse effects [ Time Frame: 1 to 120 minutes (Intraoperatively) ]
    Occurrence of any adverse events like hypotension, bradycardia, hallucination, nausea and vomiting.

  5. Modified Wilson Sedation Scale [ Time Frame: 1 to 120 minutes (Intraoperatively) ]
    Sedation score of the patients will be noted (1=Oriented, 2=Drowsy,3=Arousable,4=Unarousable)

  6. Modified Aldrerte Score [ Time Frame: 10 to 30 minutes (In post anesthesia care unit) ]
    Time required by patients of each group to be discharged from the PACU will be noted bu using Modified Aldrerte Score (Score of 9-10=can be discharged, 8 or less=close monitoring needed)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Inclusion criteria:

    Patients undergoing Subarachnoid block for proximal fracture femur

    1. Age: above 18 years
    2. ASA PS I, II
  2. Exclusion criteria:

    1. Refusal to participate in the study
    2. Other painful co- morbidities
    3. Allergy or any contraindication to study medication
    4. Any contraindication to subarachnoid block
    5. Analgesics 8 hours prior to performing sunarachnoid block
    6. Pathologic fractures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04418674


Contacts
Layout table for location contacts
Contact: Jenny Bajracharya, MD 9841455882 ext +977 bajracharya.jenny@gmail.com
Contact: Krishna Pokharel, MD 9841986321 ext +977 drkrishnapokharel@gmail.com

Locations
Layout table for location information
Nepal
B P Koirala Institute of Health and Sciences Recruiting
Dharān Bāzār, Sunsari, Nepal, 56700
Contact: Jenny Bajracharya, MBBS, MD    9841455882 ext +977    bajracharya.jenny@gmail.com   
Contact: Krishna Pokharel, MBBS, MD    0941986321 ext +977    drkrishnapokharel@gmail.com   
Principal Investigator: Jenny Bajracharya, MD         
Sub-Investigator: Krishna Pokharel, MD         
Sub-Investigator: Birendra Prasad Sah, MD         
Sub-Investigator: Sindhu Khatiwada, MD         
Sub-Investigator: Asish Subedi, MD         
B P Koirala Institute of Health and sciences Recruiting
Dharān Bāzār, Sunsari, Nepal
Contact: Jenny Bajracharya, MD    9841455882 ext +977    bajracharya.jenny@gmail.com   
Sponsors and Collaborators
Jenny Bajracharya
Investigators
Layout table for investigator information
Study Chair: Bishnu Pokharel, MS B P Koirala Institute of Health and Sciences
Publications:
The safety, benefits and effectiveness of different intravenous subanesthetic doses of ketamine when combined with small dose of midazolam before combined spinal epidural technique for Orthopedic Lower Extremity Surgery Moataz Moataz Morad El-Tawil Anesthesia Department, Faculty of Medicine, Menoufya University Abstract
Aral A Mohammed, MD*, Mayada M Ali, MD.Ketamine analgesia before spinal anesthesia for fractured femur. Sudan Med J 2015;April;51(1)

Layout table for additonal information
Responsible Party: Jenny Bajracharya, Department of Anesthesia, Principal Investigator, Junior resident, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT04418674    
Other Study ID Numbers: IRC/1597/019
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jenny Bajracharya, B.P. Koirala Institute of Health Sciences:
Spinal anesthesia
Ketamine
Fentanyl
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries
Fentanyl
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia