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Anti-shivering Effect of Ondansetron

A

Assiut University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Shivering
Ondansetron

Treatments

Drug: Normal saline
Drug: Ondansetron 4 MG
Drug: Ondansetron 8mg

Study type

Interventional

Funder types

Other

Identifiers

NCT03530007
IRB00008718/3167

Details and patient eligibility

About

Shivering is one of the most frequent complications occurring during or after spinal anesthesia with many side effects. The aim of the present study was to compare between two different doses of ondansetron for anti-shivering effect

Full description

Shivering is one of the most frequent complications occurring during or after spinal anesthesia, it affects about 40%-60 % of patients under spinal anesthesia. Intra and Post spinal shivering is distressing for the patients and anesthetist. Shivering may aggravate medical conditions in patients with limited cardiac or respiratory functions. It increases tissue oxygen demand many folds which in turn leads to increase the load on respiratory and cardiac systems to cope with increased aerobic metabolism. Shivering interferes with good patient monitoring by causing artifacts of electrocardiography, invasive and non-invasive blood pressure, pulse oximetry, etc... . Postoperatively shivering may cause discomfort to the patient, increases wound pain by stretching incision, increase the incidence of bleeding and infection.

We aim to compare the prophylactic use of two different doses of ondansetron on the incidence of shivering after spinal anesthesia in patients scheduled for lower limb surgery.

The primary outcome was percentage of patients suffering from shivering after spinal anesthesia, secondary outcomes include any side effects related to both doses.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 18-65 years
  • Both sexes
  • American Society of Anesthesiologists
  • physical status I and II
  • scheduled for lower limb surgery under spinal anesthesia

Exclusion criteria

  • Uncooperative patients
  • psychologically unstable patients
  • obese patients with BMI >30 preoperative use of ondansetron, or opioids Fever Patients with some clinical conditions like hypo- or hyperthyroidism, Parkinson's disease.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 3 patient groups

normal saline
Active Comparator group
Description:
patients received normal saline for prevention of shivering during spinal anesthesia
Treatment:
Drug: Normal saline
ondansetron 4MG
Active Comparator group
Description:
patients received 4 mg of ondansetron for prevention of spinal shivering
Treatment:
Drug: Ondansetron 4 MG
ondansetron 8MG
Active Comparator group
Description:
patients received 8 mg of ondansetron for prevention of spinal shivering
Treatment:
Drug: Ondansetron 8mg

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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