Anesthesia; Reaction Clinical Trial
Official title:
Study of Comparison of the Effectiveness of Three Diagrams for Sedation in Spinal Anesthesia
Verified date | May 2014 |
Source | Universidad de Cartagena |
Contact | n/a |
Is FDA regulated | No |
Health authority | Colombia: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | June 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Colombia | Universidad de Cartagena | Cartagena | Bolívar |
Lead Sponsor | Collaborator |
---|---|
Universidad de Cartagena |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sedation level reached according RANSAY SCALE with the use of three schemes sedation to spinal anesthesia | 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 | one year | Yes |
Secondary | Number of participants satisfied with the use of three schemes sedation to spinal anesthesia | 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. | one year | Yes |
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