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Prevention of Post-Operative Shivering

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Completed
Early Phase 1

Conditions

Post-Operative Shivering

Treatments

Drug: ondansetron
Drug: paracetamol
Drug: normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT04682743
N-122-2020

Details and patient eligibility

About

Shivering and vasoconstriction are thermoregulatory mechanisms that are required to increase core body temperature (BT) in patients with core hypothermia.

paracetamol is an antipyretic drug that has been in clinical use for a long time.

It can lower the BT of febrile and nonfebrile patients. A previous study demonstrated that orally administered paracetamol can suppress in a dose-dependent manner the increase in the BT of patients with acute ischemic stroke. However, few studies have evaluated the effects of paracetamol on postoperative shivering.

Enrollment

120 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Adult patients between 18-40 years.
  • ASA physical status I and II
  • Both genders
  • Patients scheduled for elective mega-liposuction surgery under combined general epidural anesthesia

Exclusion criteria

  • Patients who refused to participate in the study,
  • ASA physical status more than II,
  • any contraindications to regional anesthesia,
  • surgical duration less than two hours or exceeding six hours,
  • giving history of any of the following; allergy to the study medications used, system impairment, alcohol abuse, any endocrine disease affecting body temperature such as thyroid disorders,
  • any psychiatric or neurological disorders, convulsions, patient receiving vasodilators or medications likely to alter thermoregulation,
  • Finally if their body temperature was recorded to surpass 37.5ºC or <36.5°C before enrolment.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 3 patient groups

saline group
Sham Comparator group
Treatment:
Drug: normal saline
ondansetron group
Active Comparator group
Treatment:
Drug: ondansetron
paracetamol group
Active Comparator group
Treatment:
Drug: paracetamol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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