Efficacy of Ketamine-Propofol for Short Surgical Procedures

NCT01651988 | Completed Phase 4 DMC

• 1 other identifier: Ketofol-001
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anesthesia; Reaction

Keywords

ketamine; propofol anesthesia

Outcome Measures

Primary Outcomes (1)

• EFFICACY OF KETAMINE-PROPOFOL FOR SHORT SURGICAL PROCEDURES

  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%.

  7 months

Study Arms (2)

Ketofol 1:1

ACTIVE COMPARATOR

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

Ketofol 1:2

EXPERIMENTAL

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

Interventions

Ketamina-Propofol Combination DRUG

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

Also known as: Ketofol

Ketofol 1:1; Ketofol 1:2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients who have not eaten solid food within 8 hours before or liquids in the two hours before
• Be an adult or emancipated minor

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Cartagena: lead

Study Officials

• Ricardo Poveda, Resident

  University of Cartagena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Resident

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 27, 2012
• Study Start: March 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 27, 2012

Record last verified: 2012-07