Anesthesia; Reaction Clinical Trial
Official title:
Study of Comparison of the Effectiveness of Three Diagrams for Sedation in Spinal Anesthesia
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
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