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Efficacy of Ketamine-Propofol for Short Surgical Procedures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Ricardo Poveda Jaramillo, Universidad de Cartagena
ClinicalTrials.gov Identifier:
NCT01651988
First received: July 2, 2012
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: EFFICACY OF KETAMINE-PROPOFOL COMBINATION FOR SHORT SURGICAL PROCEDURES

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidad de Cartagena:

Primary Outcome Measures:
  • EFFICACY OF KETAMINE-PROPOFOL FOR SHORT SURGICAL PROCEDURES [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651988

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

No publications provided

Responsible Party: Dr. Ricardo Poveda Jaramillo, Anesthesiology Resident, Universidad de Cartagena
ClinicalTrials.gov Identifier: NCT01651988     History of Changes
Other Study ID Numbers: Ketofol-001
Study First Received: July 2, 2012
Last Updated: July 26, 2012
Health Authority: Colombia: Institutional Review Board

Keywords provided by Universidad de Cartagena:
ketamine
propofol anesthesia

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

ClinicalTrials.gov processed this record on June 17, 2013