Granisteron Versus Ondansetron for Prophylaxis Against Post-Spinal Anesthesia Shivering: a Randomized Controlled Study

NCT04294992 | Unknown

• 1 other identifier: MS-265-2019
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

3\. Scientific committee approval (Was it scientifically approved by the department?) Yes Date of approval: Sunday ,1ST September,2019 Background and Rationale: Regional anesthesia is commonly associated with intraoperative shivering which reaches 40-60%. Spinal anesthesia contributes in impairment of thermoregulation, and predisposes patients to hypothermia, which reduces the threshold for shivering and vasoconstriction. Other mechanisms responsible for shivering include increased sympathetic tone, pain, and systemic release of pyrogens. Shivering causes increase in metabolic activity, oxygen consumption, intracranial, and intraocular pressure. Shivering is also responsible for increasing cardiac output, peripheral resistance, carbon dioxide production, and lactic acidosis. Furthermore, shivering interferes with electrocardiogram (ECG) and pulse oximetry. 1 Post anaesthetic shivering is one of the most frequent problems in the early recovery phase following general anaesthesia. It was considered as the sixth most important problem of current clinical anaesthesiology among 33 low morbidity clinical outcomes. Previous studies have found that shivering occurs up to 60% of patients in the postoperative period and varies according to sex, age, drugs used for anaesthesia and the duration for the surgery.2 Since shivering is a response to hypothermia, body temperature should be maintained within 36.5-37.5°C, however, shivering may be also seen in normothermic patients undergoing regional anesthesia. A number of factors responsible for developing of hypothermia in regional anesthesia including age, level of sensory block, temperature of the operating room and infusion solution.3 Perioperative hypothermia and shivering can be prevented by physical methods like surface warming or pharmacologically by drugs such as pethidine, tramadol, clonidine, doxapram, opioids, neostigmine, magnesium sulfate and ketamine.4 Pethidine is the most commonly used drug for post spinal anesthesia shivering. The disadvantage of pethidine is that it can cause respiratory depression in the presence of previously administered opioids or anaesthetics. Moreover, hypotension, nausea and vomiting are also important side effect of pethidine.5 Pethidine, which is considered as a time-tested drug for control of shivering, can have adverse effects such as respiratory depression, nausea, and vomiting. which begs to investigate the efficacy of other drugs.6 5-HT antagonists had been effectively introduced for management of perioperative shivering by inhibiting thermoregulatory response by central mechanism. Ondansetron is a 5-HT antagonist which had been effectively used in treatment of postoperative shivering.7 Granisteron, a new generation of 5-HT antagonists, had been also reported effective in the prevention of Postoperative shivering.9-10 No data are available about the comparison of both drugs, ondansetron and granisteron, for prophylaxis against post-spinal shivering The aim of the investigator's study is to compare the efficacy of granisteron to ondansetron for prevention of intra- and post spinal anaesthesia shivering.

Conditions

Spinal Anaesthetic

Outcome Measures

Primary Outcomes (1)

• perioperative spinal induced shivering

  incidence of shivering during spinal anaesthsia

  during spinal anaesthesia

Secondary Outcomes (1)

• incidence of perioperative nausea and vomiting

  during spinal anaethesia

Study Arms (2)

Granisteron group

EXPERIMENTAL

Drug: Ondansetron 8mg

Ondansetron group

ACTIVE COMPARATOR

Drug: Ondansetron 8mg

Interventions

Ondansetron 8mg DRUG

Study drugs will be prepared, diluted to a volume of 10 mL using saline 0.9%

Granisteron group; Ondansetron group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• With ASA physical status I and II
• Scheduled to undergo lower half surgery under spinal anesthesia such as lower limb orthopedic surgeries, lower limb plastic surgeries, or lower abdominal surgeries.

You may not qualify if:

• Patient refusal
• Patients with age above 60 years and below 18 years.
• Pregnant
• Patients with contraindications to spinal anesthesia
• Preoperative fever or hypothermia (temperature \>38°C or below 36.5°C), hypo or hyperthyroidism, a requirement for blood or blood product transfusion during surgery and medications likely to alter thermoregulation or nausea and vomiting, will be excluded.
• Patients with significant cardiopulmonary disease (i.e. ejection fraction \<40% and/or SpO2 \< 92% on room air) or psychological disorder
• impaired renal (serum creatinine \> 2 mg/dL) or hepatic function (class B or C on Child-Pugh score)
• Procedures with anticipated duration less than 90 minutes or more than 180 min, those received saddle block or those required vasodilator administration
• Allergy to any of the study drugs will be excluded from the study

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr alainy medical school

Cairo, 12566, Egypt

Location

Related Publications (2)

• Nallam SR, Cherukuru K, Sateesh G. Efficacy of Intravenous Ondansetron for Prevention of Postspinal Shivering during Lower Segment Cesarean Section: A Double-Blinded Randomized Trial. Anesth Essays Res. 2017 Apr-Jun;11(2):508-513. doi: 10.4103/aer.AER_26_17.

  PMID: 28663651 BACKGROUND

• Iqbal A, Ahmed A, Rudra A, Wankhede RG, Sengupta S, Das T, Roy D. Prophylactic granisetron vs pethidine for the prevention of postoperative shivering: a randomized control trial. Indian J Anaesth. 2009 Jun;53(3):330-4.

  PMID: 20640142 BACKGROUND

MeSH Terms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Ayman Abougabal, PHD

CONTACT

00201020671408; ayman.abouagabal@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anaesthesia, SICU and pain management

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: April 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

EG (1)