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

NCT02136641 | Completed Phase 4 DMC

• 2 other identifiers: NCT01651989p-2011-1682
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Reaction

Keywords

Anesthesia; Spinal Anesthesia; Conscious Sedation; Operating Rooms.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of participants satisfied with the use of three schemes sedation to spinal anesthesia

  one year

Study Arms (3)

Midazolam

ACTIVE COMPARATOR

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

Midazolam+Fentanyl Combination

EXPERIMENTAL

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

Midazolam+Ketamine Combination

EXPERIMENTAL

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

Interventions

Midazolam DRUG

Was applied Midazolam 0.03 mg / kg, IV (in the vein), single dose.

Midazolam

Midazolam+Fentanyl Combination DRUG

Was applied Midazolam 0.015 mg / Kg + Fentanyl 0.8mcg/kg, IV (in the vein), single dose.

Also known as: Midazolam, Fentanyl

Midazolam+Fentanyl Combination

Midazolam+Ketamine Combination DRUG

Was applied Midazolam 0,015 mg / Kg + ketamine 0.25 mg / kg, IV (in the vein), single dose.

Also known as: Midazolam, Ketamine hydrochloride

Midazolam+Ketamine Combination

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Cartagena: lead

Study Sites (1)

Universidad de Cartagena

Cartagena, Departamento de Bolívar, 1051, Colombia

Location

MeSH Terms

Interventions

Midazolam; Fentanyl; Ketamine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• FRANCISCO BERMUDEZ GUERRERO, M.D

  Universidad de 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: Specialist in Anesthesiology

Study Record Dates

• First Submitted: May 3, 2014
• First Posted: May 13, 2014
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

CO (1)