Efficacy of Oral Ondansetron Strips on Prevention of Post-Spinal Shivering
ConditionPost-Spinal Shivering
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCairo University
About this trial
This study aims to investigate the efficacy of oral ondansetron film strips on the incidence of post-spinal shivering in patients undergoing surgeries using spinal anesthesia at Kasr Alainy hospitals, Cairo University.
This prospective, double-blinded, randomized controlled study will be conducted on 50 patients aged from 18 to 65 years of both sexes with ASA I, II who are scheduled for elective surgical procedures under spinal anesthesia in the lower half of the body such as orthopedic, urological, or general surgeries. Patients will be divided into two equal groups: Group (O) will receive oral ondansetron in the form of an oral soluble film 4 mg strip immediately before insertion of IV cannula and group (C) will receive a placebo in the form of an oral peppermint strip immediately before insertion of the IV cannula.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiologists (ASA) physical status I, II.
Patients underwent elective surgical procedures under spinal anesthesia in the lower half of the body such as orthopedic, urological, or general surgeries.
Disqualifiers
Patient refusal.
Morbid obese patients or those who were not candidates for spinal anesthesia.
Pregnant females.
Patients with comorbidities such as severe cardiopulmonary, severe hepatic or renal diseases, thyroid disorders, and convulsions.
Trial design
Design model
Parallel
Treatments tested in this trial
Oral ondansetron strips
DrugIn the anesthesia preparation room and before the insertion of the peripheral IV cannula, patients in group O will receive oral ondansetron in the form of an oral soluble film 4 mg strip.
Placebo (oral peppermint strip)
Other interventionIn the anesthesia preparation room and before the insertion of the peripheral IV cannula, patients in group C will receive a placebo in the form of an oral peppermint strip.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Group OActive comparator 1 intervention
Group B: Group CPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of shivering.
It is defined by the highest shivering score ≥ 3 at any time starting from 15 min after lumber puncture until 180 min following it.
Time frame
starting from 15 minutes after lumber puncture until 180 minutes following it and postoperative.Secondary outcomes
1
The onset time of significant shivering
Time in min from the onset of significant shivering ≥ 3 on shivering score
Time frame
started from 15 minutes after lumbar injection until 180 minutes following lumbar injection and postoperative2
Incidence of hypothermia
Core body temperature will be measured by ear thermometer immediately before lumbar puncture (base level), and then at 15-minute intervals until 180 min after lumbar puncture and postoperative. Hypothermia will be defined as a tympanic membrane temperature \< 36.5◦ C.
Time frame
started from 15 minutes after lumbar injection until 180 minutes after lumbar injection and postoperative.3
The shivering score
Shivering score will be assessed according to the Bedside shivering assessment score (BSAS) as: Grade I: Mild fasciculation of face, neck, or head, or peripheral vasoconstriction, Grade II: Visible tremor involving one muscle group, Grade III Muscular activity in more than one muscle group but not generalized, and Grade IV: Gross muscular activity involving the entire body. The minimum is grade I and the maximum is Grade IV. Higher grades mean increased severity.
Time frame
will be assessed at 15 minutes intervals during the operation and in the recovery room started from 15 minutes after the lumbar puncture until 180 minutes after the lumbar puncture and postoperative.4
Incidence of patients given pethidine
If shivering scores ≥ 3, 30 mg of IV pethidine will be administered as a rescue dose.
Time frame
started from 15 minutes after the lumbar puncture until 180 minutes after the lumbar puncture and postoperativde.Other outcomes
1
Demographic data including age, sex, and weight
Time frame
started immediately preoperatively until 1 minute before lumbar puncture2
ASA physical status.
Time frame
started immediately preoperatively until 1 minute before lumbar puncture3
Heart rate
Time frame
will be recorded at the following intervals: baseline (immediately before induction of spinal block), one minute after lumbar puncture, every 10 minutes in the first 30 minutes, then at 60 and 90 minutes intraoperatively and 30 minutes postoperatively4
mean arterial blood pressure
Time frame
will be recorded at the following intervals: baseline (immediately before induction of spinal block), one minute after lumbar puncture, every 10 minutes in the first 30 minutes, then at 60 and 90 minutes intraoperatively and 30 minutes postoperativelyLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: