Skip to content

The comparison of Clonidine and Granisetron in the prevention of postoperative shivering, nausea and vomiting.

The comparison of Clonidine and Granisetron in the prevention of postoperative shivering, nausea and vomiting.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201205089684N1
Enrollment
100
Registered
2012-06-23
Start date
2012-06-21
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

General anesthesia.

Interventions

Intervention 1: Intervention group: Administration of Granisetron 40 mcg/kg intravenous immediately before induction of General Anesthesia. Intervention 2: Control group:A tablet 0.2 mg clonidine with
Treatment - Drugs
Intervention group: Administration of Granisetron 40 mcg/kg intravenous immediately before induction of General Anesthesia.
Control group:A tablet 0.2 mg clonidine with 50 ml of water will be administered and performed induction of general anesthesia after 60 minutes.

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: elective orthopedic surgery, the patients' age ranged from 18 to 65 years old; BMI (Body Mass Index) less than 30 kg/m2 and a maximum of 2 hours of surgery time. Exclusion criteria: emergency surgery; history of seizures, diabetes, Parkinson's or any other diseases that can cause shivering; motion sickness and migraine; history of psychotropic substances or sedatives drugs; addiction to alcohol or opoide; blood transfusion and that products, administration of vasoactive drugs during anesthesia; existence of active infection before anesthesia; receive any anti vomiting 48 hours preoperative; intra operative use of propofol; systolic blood pressure less than 90 or greater than 160 mmHg; patients with difficult intubation and body temperature less than 36 or more than 37.5 degrees centigrade

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Nausea and vomiting. Timepoint: During recovery and world at the 6 hours. Method of measurement: The patients are assessed of the incidence of nausea and vomiting, by a trained individual which is not aware to administrate any drug, and then items to be recorded. Nausea will be assess and recorded base on feeling with the scale of a Multiple Choice without nausea, moderate and severe nausea. If patient can feel nausea at least 5 minutes it is considered an episode of nausea. The severe vomiting will be recorded base on without vomiting, once vomiting (mild), two or three occasions vomiting (moderate) and more than three times vomiting (severe). If there was between vomiting an interspaced at least one minute, each one of them is considered on episode vomiting. Meanwhile, retching can be considered equivalent to vomiting. In items that, patients had a severe nausea or twice vomiting and or the patient's own requests, are prescribed 8 mg Intravenous Metoclopramide as anti-nausea drugs supplemental.;Shiviring. Timepoint: The end of anesthesia and during recovery. Method of measurement: The shivering of patients will be evaluated after end anesthesia and during recovery with visual assessment scale, including: Zero =the cases without shivering, degree 1 = status of vasoconstriction and peripheral cyanosis without other cause (or straight hair, but without visible muscular activity), degree 2 = visible muscular activity confined to one muscle group (or mild fasciculation face and neck), degree 3= Visible, Shivering in more than one group of muscle, degree 4= Muscle activity visible that include all body. The items by a person trained and experienced and without the knowledge of the prescribed medicines will be assessed and are recorded in the relevant information. If grade of shivering was 3 or 4, the patient is treated with 25 mg intravenous pethidine.

Secondary

MeasureTime frame
Systolic blood pressure. Timepoint: Variables of vital signs at intervals before, 10 and 20 minutes after drug administration and immediately after transfer to the recovery are controlled. Method of measurement: Sphygmomanometer.;Core temperature (Tempan). Timepoint: Variables of vital signs at intervals before, 10 and 20 minutes after drug administration and immediately after transfer to the recovery are controlled. Method of measurement: Thermometer Tempanic.;Diastolic blood pressure. Timepoint: Variables of vital signs at intervals before, 10 and 20 minutes after drug administration and immediately after transfer to the recovery are controlled. Method of measurement: Sphygmomanometer.;Surface temperature (axillary). Timepoint: Variables of vital signs at intervals before, 10 and 20 minutes after drug administration and immediately after transfer to the recovery are controlled. Method of measurement: Thermometer's Axillary.;Heart rate. Timepoint: Variables of vital signs at intervals before, 10 and 20 minutes after drug administration and immediately after transfer to the recovery are controlled. Method of measurement: Pulsoxymetri.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactOmmelaila Rabiee

Research Assistant of Babol University of Medical Sciences

syasin36@yahoo.com - ol.rabiee@gmail.com – amir.9632@gmail.com+98 11 1223 4274

Outcome results

None listed

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