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Prophylactic use of ondansetron versus ketamine - midazolam combination for prevention of shivering during spinal anesthesia

Prophylactic use of intravenous ondansetron versus ketamine - midazolam combination for prevention of shivering during spinal anesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201307155362N7
Enrollment
90
Registered
2014-03-11
Start date
2009-03-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

shivering after anesthesia. Hypothermia following anaesthesia

Interventions

adding 0.25 mg ketamin and 37.5 mg midazolam intravenous in KM group
Intervention 1: adding normal saline in control group. Intervention 2: adding 8 mg ondansetron intravenous in O group. Intervention 3: adding 0.25 mg ketamin and 37.5 mg midazolam intravenous in KM gr
Treatment - Drugs
adding normal saline in control group
adding 8 mg ondansetron intravenous in O group

Sponsors

Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criterias:(ASA) I to II patients; aged 18-65 years; candidate for elective orthopedic surgery with spinal anesthesia Exclusion criterias: psychological disorder; cardiopulmonary disease; hypo- or hyperthyroidism; initial body temperature > 38.0 ºC or < 36 ºC; without known history of alcohol or substance abuse ; history of receiving vasodilators or similar medications likely to alter thermoregulation; any change in technique of anesthesia ; sever bleeding which needed to blood transfusion

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Shivering. Timepoint: each 5 minutes untill 24 hours after surgery. Method of measurement: observation.

Secondary

MeasureTime frame
Side effects of drugs such as hullosination,nausea,vomitting and hypotension. Timepoint: after injection of drugs untill 24 hoiurs. Method of measurement: observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadreza Safavi

Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences

safavi@med.mui.ac.ir+98 31 1668 5555

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026