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Efficacy of Ketamine-Propofol for Short Surgical Procedures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01651988
First Posted: July 27, 2012
Last Update Posted: July 27, 2012
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.
Information provided by (Responsible Party):
Dr. Ricardo Poveda Jaramillo, Universidad de Cartagena
  Purpose

OBJECTIVE: To determine the efficacy of ketamine-propofol anesthesia in a mixture 1:2 (1 mg of ketamine per 2 mg of propofol) for short minimally invasive surgical procedures.

METHODS: The investigators performed a prospective study through randomization of 77 patients undergoing short surgical procedures in two study groups: one received a mixture of ketamine-propofol in a 1:1 ratio, and the other received a 1:2 mixture. Data were stored in an Excel spreadsheet and analyzed using the statistical program Epi-Info (TM) 3.5.3. The investigators performed the comparison of qualitative and quantitative variables.

KEY WORDS: ketamine, propofol, anesthesia.


Condition Intervention Phase
Anesthesia; Reaction Drug: Ketamina-Propofol Combination Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: EFFICACY OF KETAMINE-PROPOFOL COMBINATION FOR SHORT SURGICAL PROCEDURES

Resource links provided by NLM:


Further study details as provided by Dr. Ricardo Poveda Jaramillo, Universidad de Cartagena:

Primary Outcome Measures:
  • EFFICACY OF KETAMINE-PROPOFOL FOR SHORT SURGICAL PROCEDURES [ Time Frame: 7 months ]
    Sedation / analgesia was considered successful if the procedure was completed without the need for other anesthetic drugs are different from the protocol, and yes no adverse effects to oblige the completion of the procedure. Apnea was defined as cessation of breathing for at least 20 seconds. Hypotension was defined as 20% decrease in mean arterial pressure. Bradycardia was defined as a pulse of less than two standard deviations below normal values defined by the American Heart Association (AHA_ for its acronym in Ingles_). Hypoxia was defined by an oxygen saturation of less than 90%.


Enrollment: 77
Study Start Date: March 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ketofol 1:1
1. Anesthesia-sedation KETOFOL 1-1: Two milligrams per kilogram of ketamine plus two milligrams per kilogram of propofol in a solution 1:1 (one milligram of ketamine per one milligram of propofol) was given to those patients randomly asigned to this group, who were scheduled for any short surgical procedures previously defined in the inclusion criteria.
Drug: Ketamina-Propofol Combination

After randomization to the study group, the patients were given:

Procedures < 10 minutes

  1. Ketamine-Propofol Combination KETOFOL 1:1

    • Propofol: 0.2 cc/kg (10 mg/cc = 2 mg/kg)
    • Ketamine: cc/kg 0.04 (50 mg/cc = 2 mg/kg)
    • Simple 1% lidocaine: 0,1 cc/kg (10 mg/cc = 1 mg/kg)
  2. Ketamine-Propofol Combination KETOFOL 1:2

    • Propofol: 0.2 cc/kg (10 mg/cc = 2 mg/kg)
    • Ketamine: 0.02 cc/kg (50 mg/cc = 1 mg/kg)
    • Simple 1% lidocaine: 0,1 cc/kg (10 mg/cc = 1 mg/kg)

Procedures > 10 minutes

In addition to the initial bolus, an infusion was started:

KETOFOL 1:1

20 cc of propofol (10 mg/cc = 200 mg in total) 4 cc of ketamine (50 mg/cc = 200 mg in total) 10cc lidocaine 1% simple (10 mg/cc = 100 mg in total) 66 cc 0.9% SSN

KETOFOL 1:2

20 cc of propofol (10 mg/cc = 200 mg in total) 2 cc of ketamine (50 mg/cc = 100 mg in total) 10cc lidocaine 1% simple (10 mg/cc = 100 mg in total) 68 cc 0.9% SSN

Speed infusion:

0,03cc/kg/min

Other Name: Ketofol
Experimental: Ketofol 1:2
2. Anesthesia-sedation KETOFOL 1-2: One milligram per kilogram of ketamine plus two milligrams per kilogram of propofol in a solution 1:2 (one milligram of ketamine per two milligrams of propofol) was given to those patients randomly asigned to this group, who were scheduled for any short surgical procedure previously defined in the inclusion criteria.
Drug: Ketamina-Propofol Combination

After randomization to the study group, the patients were given:

Procedures < 10 minutes

  1. Ketamine-Propofol Combination KETOFOL 1:1

    • Propofol: 0.2 cc/kg (10 mg/cc = 2 mg/kg)
    • Ketamine: cc/kg 0.04 (50 mg/cc = 2 mg/kg)
    • Simple 1% lidocaine: 0,1 cc/kg (10 mg/cc = 1 mg/kg)
  2. Ketamine-Propofol Combination KETOFOL 1:2

    • Propofol: 0.2 cc/kg (10 mg/cc = 2 mg/kg)
    • Ketamine: 0.02 cc/kg (50 mg/cc = 1 mg/kg)
    • Simple 1% lidocaine: 0,1 cc/kg (10 mg/cc = 1 mg/kg)

Procedures > 10 minutes

In addition to the initial bolus, an infusion was started:

KETOFOL 1:1

20 cc of propofol (10 mg/cc = 200 mg in total) 4 cc of ketamine (50 mg/cc = 200 mg in total) 10cc lidocaine 1% simple (10 mg/cc = 100 mg in total) 66 cc 0.9% SSN

KETOFOL 1:2

20 cc of propofol (10 mg/cc = 200 mg in total) 2 cc of ketamine (50 mg/cc = 100 mg in total) 10cc lidocaine 1% simple (10 mg/cc = 100 mg in total) 68 cc 0.9% SSN

Speed infusion:

0,03cc/kg/min

Other Name: Ketofol

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient scheduled for minimally invasive procedures less than an hour to complete: reduction of dislocations and fractures, lavage and debridement of ulcers, drainage of abscesses, removal of osteosynthesis material, hernia umbilical, thoracotomies, circumcision, curettage, suturing tissue soft, burn care, etc.
  2. Patients who have not eaten solid food within 8 hours before or liquids in the two hours before
  3. Be an adult or emancipated minor

Exclusion Criteria:

  1. An acute lung infection
  2. Procedures involving stimulation of the posterior pharynx
  3. Coronary heart disease, CHD, and angina or suspected aortic dissection
  4. History of uncontrolled hypertension or BP > 140/90mmHg
  5. Injury cerebral focal neurological deficit or loss of consciousness
  6. Mass in CNS, hydrocephalus or other conditions with increased intracranial pressure.
  7. Glaucoma or eye damage
  8. History of porphyrias
  9. Prior hyperthyroidism or thyroid hormone replacement
  10. Pregnancy or lactation Major psychiatric disorder
  11. Previous mild allergic reaction to ketamine, propofol, lidocaine, or egg albumin
  12. Patient who refuses to provide informed consent
  Contacts and Locations
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): NCT01651988


Sponsors and Collaborators
Universidad de Cartagena
Investigators
Principal Investigator: Ricardo Poveda, Resident University of Cartagena
  More Information

Responsible Party: Dr. Ricardo Poveda Jaramillo, Anesthesiology Resident, Universidad de Cartagena
ClinicalTrials.gov Identifier: NCT01651988     History of Changes
Other Study ID Numbers: Ketofol-001
First Submitted: July 2, 2012
First Posted: July 27, 2012
Last Update Posted: July 27, 2012
Last Verified: July 2012

Keywords provided by Dr. Ricardo Poveda Jaramillo, Universidad de Cartagena:
ketamine
propofol anesthesia

Additional relevant MeSH terms:
Propofol
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action