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The investigation of effects of dexmedetomedine, ondansetron and pethidin on postoperative shivering

Comparison of the prophylactic effects of intravenous injection of Dexmedetomidine, Ondansetron, and pethidine on postoperative shivering of abdominal surgery under general anesthesia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160307026950N18
Enrollment
128
Registered
2020-04-01
Start date
2020-09-22
Completion date
Unknown
Last updated
2022-08-29

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

Conditions

postoperative shivering.

Interventions

Intervention 1: Intervention group D: First the written consent will be obtained from patients. after placing the patients on the bed, standard monitoring will be applied (including a pulse oximeter,
0.1 mg/kg Ondansetron will be injected after discontinuing the anesthetic drug, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered
First the written consent will be obtained from patients. after placing the patients on the bed, standard monitoring devices will be applied (including a pulse oximeter, capnograph, Manometer,ECG and

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: ASA class I and II Candidate for abdominal surgery under general anesthesia The range from 18-60 years of age The patient's consent to participate in the study

Exclusion criteria

Exclusion criteria: A History of TCA, MAOI, vasoactive agent, painkiller and opiate medication Musculoskeletal and nervous system diseases, thyroid diseases Dysautonomia, fever, pregnancy, obesity(BMI>27) The history of cardiovascular, respiratory, enocrin or neurologic diseases Allergic to sulfate of magnesium, ketamine and pethidin

Design outcomes

Primary

MeasureTime frame
Shivering. Timepoint: On arrival to the recovery room and then every 15 minutes for one hour. Method of measurement: Shivering severity is assessed by Crassly and Mahajan Score.;Central temperature. Timepoint: Before surgery, before drug administration, after intubation, every 15 minutes during the anesthesia, at the end of anesthesia, after extubation, on arrival to the recovery room and then every 15 minutes for one hour. Method of measurement: Tympanic thermometer.;Peripheral temperature. Timepoint: Before surgery, before drug administration, after intubation, every 15 minutes during the anesthesia, at the end of anesthesia, after extubation, on arrival to the recovery room and then every 15 minutes for one hour. Method of measurement: Thermometer.;The level of sedation. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Using the Ramsay Sedation Scale.;Severity of Pain. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Using the Visual Analogue Scale.;Systolic blood pressure. Timepoint: Before surgery, every 15 minutes during the anesthesia, on arrival to the recovery room and then every 15 minutes. Method of measurement: Non invasive manometer.;Diastolic blood pressure. Timepoint: Before surgery, every 15 minutes during the anesthesia, on arrival to the recovery room and then every 15 minutes. Method of measurement: Non invasive manometer.;Oxygen saturation. Timepoint: since entering the operating room until leaving the recovery room. Method of measurement: Pulse oximeter.;Heart rate. Timepoint: since entering the operating room until leaving the recovery room. Method of measurement: Heart monitoring device.;Mean Arterial Blood Pressure. Timepoint: Before surgery, every 15 minutes during the anesthesia, on arrival to the recovery room and then every 15 minutes. Method of measurement: Non invasive blood pressure

Secondary

MeasureTime frame
Nausea. Timepoint: Recovery length. Method of measurement: Questioning.;Vomiting. Timepoint: Recovery length. Method of measurement: Observing.;Itching. Timepoint: Recovery length. Method of measurement: Questioning.;Atropine taken dose. Timepoint: Since the beginning of the operation until the end of the recovery length. Method of measurement: Asking from the anesthesia technician.;Pethidine taken dose. Timepoint: Since the beginning of the operation until the end of the recovery length. Method of measurement: Asking from the anesthesia technician.;Ephedrine taken dose. Timepoint: Since the beginning of the operation until the end of the recovery length. Method of measurement: Asking from the anesthesia technician.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahsa Heydari

Esfahan University of Medical Sciences

heydari72.mahsa@gmail.com+98 31 3668 0048

Outcome results

None listed

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