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Study of Comparison of the Effectiveness of Three Diagrams for Sedation in Spinal Anesthesia

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ClinicalTrials.gov Identifier: NCT02136641
Recruitment Status : Completed
First Posted : May 13, 2014
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):
FRANCISCO JOSE BERMUDEZ GUERRERO, Universidad de Cartagena

Brief Summary:

Objective: To determine the efficacy of sedation schemes to sedation in patients about to undergo spinal anesthesia.

Methods: Pilot study, clinical type, randomized, prospective, single-blind, in which the investigators compared three schemes for sedation in patients undergoing spinal anesthesia.

Keywords: Anesthesia, Spinal Anesthesia, Conscious Sedation, Operating Rooms.


Condition or disease Intervention/treatment Phase
Anesthesia; Reaction Drug: Midazolam Drug: Midazolam+Fentanyl Combination Drug: Midazolam+Ketamine Combination Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Study of Comparison of the Effectiveness of Three Diagrams for Sedation in Spinal Anesthesia
Study Start Date : June 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Midazolam
1. Sedation with Midazolam 0.03 mg / kg, Intravenous, administered as a single dose. Was given to those patients randomly assigned to this group, who were scheduled for procedures previously defined in the inclusion criteria.
Drug: Midazolam
Was applied Midazolam 0.03 mg / kg, IV (in the vein), single dose.

Experimental: Midazolam+Fentanyl Combination
2. Sedation with Midazolam 0.015 mg / Kg + Fentanyl 0.8mcg/kg, Intravenous, administered as a single dose. Was given to those patients randomly assigned to this group, who were scheduled for procedures previously defined in the inclusion criteria.
Drug: Midazolam+Fentanyl Combination
Was applied Midazolam 0.015 mg / Kg + Fentanyl 0.8mcg/kg, IV (in the vein), single dose.
Other Names:
  • Midazolam
  • Fentanyl

Experimental: Midazolam+Ketamine Combination
3. Sedation with Midazolam 0,015 mg / Kg + ketamine 0.25 mg / kg, Intravenous, administered as a single dose. Was given to those patients randomly assigned to this group, who were scheduled for procedures previously defined in the inclusion criteria.
Drug: Midazolam+Ketamine Combination
Was applied Midazolam 0,015 mg / Kg + ketamine 0.25 mg / kg, IV (in the vein), single dose.
Other Names:
  • Midazolam
  • Ketamine hydrochloride




Primary Outcome Measures :
  1. Sedation level reached according RANSAY SCALE with the use of three schemes sedation to spinal anesthesia [ Time Frame: one year ]
    Sedation/Analgesia conscious was considered adequate when a RANSAY 2 or 3 was achieved (BASED ON THE RANSAY SCALE), without the need for other anesthetic drugs are different from the protocol, has been the gold standard in many studies that evaluated sedation; as you increase the level on the scale, increasing the degree of sedation . Being awake patient can be found in a level 1, referring to an anxious and / or agitated patients in level 2, when partner is quiet and focused and have spontaneous eye opening, or a level 3 when has closed eyelids, but quickly responds to verbal stimuli. When the patient was found asleep, level 4 will be called if you are still with closed eyes and responds quickly to tactile and verbal stimuli strong, level 5 when it has a slower response and only responds to important and / or painful stimuli and level 6 when does not respond to any stimulu


Secondary Outcome Measures :
  1. Number of participants satisfied with the use of three schemes sedation to spinal anesthesia [ Time Frame: one year ]
    The Satisfaction was measured with a SATISFACTION SCALE TYPE LIKERT, this scale was used to subjectively evaluate how satisfied was the patient with spinal anesthesia under sedation, the scale is not validated, giving a score of 1 to refer to be very satisfied, 2 if only felt satisfied, a score of 3 to be dissatisfied, 4 if it meant feeling unsatisfied and finally a rating of 5 if it meant being very dissatisfied.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Scheduled for elective surgery
  • Have pre-anesthetic assessment
  • Be classified according to their risk as ASA I or ASA II
  • Having a body mass index between 18.5 and 29.99
  • Not be pregnant
  • Have a higher fasting 8 hours the day of the procedure
  • Require regional anesthetic technique without contraindications to the procedure -Can be performed with the patient in the lateral decubitus
  • Have not known history of allergy

Exclusion Criteria:

  • Malformations of the spine column level , that creates a lock troubles

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): NCT02136641


Locations
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Colombia
Universidad de Cartagena
Cartagena, Bolívar, Colombia, 1051
Sponsors and Collaborators
Universidad de Cartagena
Investigators
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Principal Investigator: FRANCISCO BERMUDEZ GUERRERO, M.D Universidad de Cartagena

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Responsible Party: FRANCISCO JOSE BERMUDEZ GUERRERO, Specialist in Anesthesiology, Universidad de Cartagena
ClinicalTrials.gov Identifier: NCT02136641     History of Changes
Other Study ID Numbers: p-2011-1682 ( Other Grant/Funding Number: Colciencias )
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: May 2014
Keywords provided by FRANCISCO JOSE BERMUDEZ GUERRERO, Universidad de Cartagena:
Anesthesia
Spinal Anesthesia
Conscious Sedation
Operating Rooms.
Additional relevant MeSH terms:
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Fentanyl
Midazolam
Ketamine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents