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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04294992
Recruitment Status : Not yet recruiting
First Posted : March 4, 2020
Last Update Posted : March 4, 2020
Information provided by (Responsible Party):
Ayman Abougabal, Kasr El Aini Hospital

Tracking Information
First Submitted Date  ICMJE March 2, 2020
First Posted Date  ICMJE March 4, 2020
Last Update Posted Date March 4, 2020
Estimated Study Start Date  ICMJE April 1, 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
perioperative spinal induced shivering [ Time Frame: during spinal anaesthesia ]
incidence of shivering during spinal anaesthsia
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2020)
incidence of perioperative nausea and vomiting [ Time Frame: during spinal anaethesia ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Granisteron Versus Ondansetron for Prophylaxis Against Post-Spinal Anesthesia Shivering: a Randomized Controlled Study
Official Title  ICMJE Granisteron Versus Ondansetron for Prophylaxis Against Post-Spinal Anesthesia Shivering: a Randomized Controlled Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Spinal Anaesthetic
Intervention  ICMJE Drug: Ondansetron 8mg
Study drugs will be prepared, diluted to a volume of 10 mL using saline 0.9%
Study Arms  ICMJE
  • Experimental: Granisteron group
    Intervention: Drug: Ondansetron 8mg
  • Active Comparator: Ondansetron group
    Intervention: Drug: Ondansetron 8mg
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2020)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • • 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.

Exclusion Criteria:

  • • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ayman Abougabal, PHD 00201020671408
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04294992
Other Study ID Numbers  ICMJE MS-265-2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ayman Abougabal, Kasr El Aini Hospital
Study Sponsor  ICMJE Kasr El Aini Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kasr El Aini Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP