Study of Comparison of the Effectiveness of Three Diagrams for Sedation in Spinal Anesthesia
Condition: Anesthesia; Reaction
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Sedation is a set of actions aimed at achieving a patient be quiet, comfortable, free of pain
      and / or bad memories as a diagnostic or therapeutic procedure is performed . Given that
      regional anesthetic techniques frequently used in clinical practice are relatively traumatic
      and painful procedures , have partnered on multiple occasions sedation, to make such
      interventions more comfortable for the patient and make it easier to peer collaboration . Not
      all anesthesiologists use sedation or indicate similarly, but the vast majority practice it.
      Some apply it consistently before or after puncture for a regional block or in the event that
      required multiple punctures, and other used only when the patient is anxious .

      There are various drugs for sedation in anesthesiology with multiple anxiolytic, amnesic, and
      analgesic to, including barbiturates, benzodiazepines, opioid analgesics, and combinations
      thereof, are proof of this ketamine, midazolam, fentanyl, propofol, dexmedetomidine, and
      others . There is a clear need to implement sedation techniques that provide effectiveness,
      safety and few side-effects as well as low cost to search anxiolysis, amnesia, analgesia and
      / or drowsiness in patients who are undergoing procedures such as spinal anesthesia .

      Reducing anxiety and decreased neurological and metabolic response to surgical trauma become
      a requirement to be treated in the anesthetic plan, sedation there plays a key role in
      seeking to ensure an adequate hemodynamic stability during locoregional anesthetic techniques
      under conscious sedation, this being, sedation in which a patient responds normally to verbal
      stimuli, with preservation of cognitive function and coordination, without alteration of the
      ventilation or cardiovascular function. The ideal state of sedation depends on the type of
      patient, type of procedure and the medications used, however it is recommended to maintain a
      level of sedation between 2 and 3 or conscious sedation, according to Ramsay sedation scale
      to achieve greater wellness and collaboration, without requiring intervention to keep the
      airway, while maintaining adequate spontaneous ventilation and cardiovascular function
      normally held.

      The objective is to determine the effectiveness of three sedation schemes in patients
      scheduled to undergo spinal anesthesia.

      MATERIALS AND METHODS A clinical trial, randomized, prospective, single-blind experimental
      study was conducted, in which three schemes were compared for sedation in patients undergoing
      spinal anesthesia. Informed consent was obtained from each of the admitted patients. The
      study was approved by the ethics committee of the University of Cartagena.

      Patients who met selection criteria were randomized (according to a table of random numbers
      generated on the website: http://stattrek.com/tables/random.aspx) to be assigned to one of
      the research groups, in the period between June 2011 and June 2012.

      3 groups were formed as follows: Group 1 was given midazolam 0.03 mg / kg, Group 2 was
      applied Midazolam 0.015 mg / Kg + Fentanyl 0.8mcg/kg and in Group 3 was used Midazolam 0,015
      mg / Kg + ketamine 0.25 mg / kg, administered as a single dose in all groups.

      Sample size, with a reliability of 95%, a power of 80% and an expected rate of improvement in
      experimental group of 80% was calculated , for a total of 75 patients, and were randomly
      assigned to one of the three study groups, each group consisted of 25 patients. The
      investigators selected all patients who met the inclusion criteria such as age between 18 and
      60 years , 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 and can be performed with the
      patient in the lateral decubitus , have not known history of allergy, and haven't as an
      exclusion criteria malformations of the spine level that would prevent a spinal block without
      difficulty.

      Procedure: assigned randomly selected for each patient using a scheme sedation, 75 numbers
      were randomly through a generator of random number tables , with a minimum value of 1 and a
      maximum value of 3, and as they selected a patient was applied corresponding scheme in
      sequential order. On admission to the operating room the patient was channeled to a
      peripheral vein 18 -20Gauge, were monitored with electrocardiogram (ECG), non -invasive blood
      pressure (NIBP) and oxygen saturation by pulse oximetry (O2Sat) by a vital signs monitor;
      hemodynamic variables were recorded income. Was applied intravenously one of the
      pre-established schemes sedation according to patient weight and oxygen was administered by
      nasal cannula 1Litre/minutes , hemodynamic changes were recorded at 2.5 and 5 minutes from
      the scheme were implemented and evaluated the Ramsay scale at the time. The patient is
      positioned for carrying the anesthetic technique, and with a Quincke needle 26 Gauge, spinal
      anesthesia by a team of experienced anesthesiology was placed, corresponding to the authors
      of this study, the number of attempts and difficulty to blockade were noted, at the end of
      the surgical procedure a satisfaction survey was performed to the patient about their
      experience with spinal block.

      The data collection was performed using a format that included sociodemographic
      characteristics, variables of interest and two measuring scales were used:

      The first was the RANSAY SCALE, which is a scale used to assess the depth of sedation , is
      validated over 30 years ago, is easy to use and 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 stimulus.

      In addition, a SATISFACTION SCALE TYPE LIKERT 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.

      Data analysis: the counting of categorical variables are reported as absolute numbers and
      percentages. Differences in baseline characteristics and post-intervention were estimated
      through hypothesis testing. For qualitative variables the Chi square test and Fisher's exact
      test was used, as appropriate. In quantitative variables of normal verified through
      Shapiro-Wilk test and comparison groups by ANOVA, this analysis was supported with Epi Info
      v7 and Stata software.

      Ethical issues: the declaration of Helsinki and the regulations in force in Colombia (1993
      Resolution No.008430 MOH 2378 and resolution 2008 on good clinical practice) was adjusted. No
      actions against incurring ethical proposals were registered there. Assessment was required by
      the ethics committee of the Hospital, who gave his endorsement to proceed with its
      development, a report of individual informed consent of patients was performed.
    

Intervention name(s): Midazolam; Midazolam+Fentanyl Combination; Midazolam+Ketamine Combination
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Was applied Midazolam 0.03 mg / kg, IV (in the vein), single dose.; Was applied Midazolam 0.015 mg / Kg + Fentanyl 0.8mcg/kg, IV (in the vein), single dose.; Was applied Midazolam 0,015 mg / Kg + ketamine 0.25 mg / kg, IV (in the vein), single dose.
Other intervention name(s): Midazolam; Fentanyl; Midazolam; Ketamine hydrochloride
Intervention MeSH terms: Midazolam; Fentanyl; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Anesthesia; Spinal Anesthesia; Conscious Sedation; Operating Rooms.