Efficacy of Oral Ondansetron Strips on Prevention of Post-Spinal Shivering

In 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 (Ondalenz, 4 mg orodispersible films of Nerhadou International Co.) and patients in group C will receive a placebo in the form of an oral peppermint strip (Listerine Cool Mint Pocketpakas).

Following the insertion of a cannula; IV midazolam at a dose of 0.05 mg/kg will be administered intravenously. Then the patient will be transferred immediately to the operating theatre.

On entering the operating room; all patients will be connected to standard ASA monitoring which included electrocardiography (ECG), non-invasive arterial blood pressure (NIBP) including systolic, diastolic, mean arterial blood pressure (MAP) and Oxygen saturation using pulse oximetry.

With the patient sitting on the operating table, the L3-L4 interspace will be identified by identification of Tuffier's line. Under complete aseptic conditions, a dural puncture will be achieved by a 22G pencil-point spinal needle that will be introduced in a paramedian (lateral) approach through the L3-4 intervertebral space. After CSF aspiration and confirmation of correct intrathecal space, 3.5 mL of Sunny Pivacaine 0.5% (hyperbaric bupivacaine 20mg/4mL amp of Sunny pharmaceutical group) plus 25 μg of fentanyl-Hameln (of Sunny pharmaceutical group) will be injected over one minute.

The sensory block will be assessed by a pinprick test and the motor block will be assessed using a modified Bromage scale (0 = no motor block; 1= hip is blocked; 2= hip and knee are blocked; 3= hip, knee, and ankle are blocked). Peak sensory level will be confirmed and if a sensory level \< T8 the patient will be excluded. If general anesthesia is needed for any reason, the patient will also be excluded from the study.

The ambient room temperature will be maintained at 24°C. IV fluids will be administered according to the conventional way as follows, hourly maintenance was the sum of A (4x first 10 Kg body weight), B (2x next 10 Kg body weight) and C (1x remaining Kg bodyweight) in addition to deficit (or fasting requirements), that will be hourly maintenance multiplied by the numbers of hours of fasting, half of it will be administered in the first hour and the second half will bne administered during second and third hours of surgery. Balanced crystalloids such as Ringer's lactate or acetate will be preferred over normal saline. Blood loss will be estimated through the surgical field, towels, gauzes and suction jar \& will be replaced by crystalloids 1:3 or colloid/blood and blood products 1:1 ratio. All IV fluids will be administered at room temperature. All patients will be covered with surgical drapes from the lower extremities up to the lower chest during the operation. No warming devices will be used. Supplementary oxygen by a face mask will be given to all patients at a rate of 6 L/min.

The tympanic temperature will be monitored and measured by using the Braun ThermoScan 5 Ear Thermometer model IRT 6500. Hypothermia will be defined as a tympanic membrane temperature \< 36.5◦ C.

Shivering score will then be assessed according to the Bedside shivering assessment score (BSAS) . If shivering scores ≥ 3, 30 mg of IV pethidine were administered as a rescue dose.

Postoperative:

Patients will be discharged to post anesthesia care unit (PACU). All patients will be monitored in the post-anesthesia care unit (PACU), covered by one cotton blanket over their entire body. The PACU temperature will be maintained at 24ºC.

The adverse effects will be assessed: allergic reaction from the used drugs, complications from the surgery done as:

Hypotension (MAP \< 20% of baseline). In case of hypotension, the patients will be managed with intravenous loading with Ringer's lactate and boluses of 10 mg ephedrine IV.

Bradycardia (HR\< 60 beats/min). In the case of bradycardia, the patients will be managed with 0.02 mg/kg atropine IV.

Respiratory depression will be considered if the respiratory rate is less than 10 breaths per minute and oxygen saturation (SpO2) was \< 92% for 30 or more seconds.

• The onset time of significant shivering [Срок оценки: started from 15 minutes after lumbar injection until 180 minutes following lumbar injection and postoperative]
• Incidence of hypothermia [Срок оценки: started from 15 minutes after lumbar injection until 180 minutes after lumbar injection and postoperative.]
• The shivering score [Срок оценки: 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.]
• Incidence of patients given pethidine [Срок оценки: started from 15 minutes after the lumbar puncture until 180 minutes after the lumbar puncture and postoperativde.]
• Correlation between the incidence of shivering score ≥ 3 and hypothermia. [Срок оценки: started 15 minutes after lumbar puncture until 180 minutes after lumbar puncture and postoperatively]
• The incidence of adverse effects [Срок оценки: started 15 minutes after lumbar puncture until 180 minutes after lumbar puncture and postoperatively]
• Correlation between the incidences of postoperative nausea, vomiting, and shivering [Срок оценки: started 15 minutes after lumbar puncture until 180 minutes after lumbar puncture and postoperatively]