The effect of granisetron in prophylaxis of intrathecal opioid induced-pruritus

Comparison of the efficacy and complications of different doses of granisetron in prophylaxis of intrathecal sufentanil induced-pruritus in patients undergoing lower limb surgery in Emam Khomeini hospital during 1391-92

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013072414149N1

Enrollment

180

Registered

2013-09-07

Start date

2012-06-09

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

intrathecal opioid induced-pruritus. other pruritus

Interventions

Intervention 1: control group:normal saline as placebo 4.5 mL intravenously. Intervention 2: group 1 : granisetron 10 mcg/kg + normal saline up to total volume of 4.5 mL intravenously. Intervention 3:

Placebo

Prevention

control group:normal saline as placebo 4.5 mL intravenously

group 1 : granisetron 10 mcg/kg + normal saline up to total volume of 4.5 mL intravenously

group 2 : granisetron 40 mcg/kg + normal saline up to total volume of 4.5 mL intravenously

group 3 : granisetron 60 mcg/kg + normal saline up to total volume of 4.5 mL intravenously

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: inclusion criteria : ASA class I-II exclusion criteria :male less than 18 years old; male more than 65 years old; fmale less than 18 years old; fmale more than 65 years old; ASA Class III; ASA Class IV; patient refuse from performing spinal block; patients with spinal deformities; patients with mental disorders; patients with local skin infections; history of anaphylaxis to local anesthetics,sufentanil and granisetron; patients with coagulation disorders; patients with severe hepatic disease; patients with renal function disorder; patients with body wheight more than 100 kilograms; patients dependent to opioid; patients with severe chronic obstructive pulmonary disease (FEV1 less than 600cc); height less than 150 cm or more than 180 cm; known cardiac disease; patients with long QTsyndrome

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pruritus. Timepoint: 30 minutes-0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: Visual Analogue Scales and Verbal Rating Scales for assessment of the severity of pruritus.	—

Secondary

Measure	Time frame
Pain. Timepoint: 30 minutes- 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: Visual Analogue Scales for assessment of pain.;Nausea. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: observation.;Vomiting. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: observation.;Shivering. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: observation.;Blood pressure. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: mmHg.;Haert rate. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: beats/min.;Respiratory rate. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours -8 to 24 hours after intervention. Method of measurement: beats/min.;Arterial oxygen saturation. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours- 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: percent.;Drowsiness. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: Ramsey sedation score.;Headache. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: observation.;Allergic reaction. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: observation.;Arrythmia. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: observation.	—

Measure

Time frame

Pain. Timepoint: 30 minutes- 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: Visual Analogue Scales for assessment of pain.;Nausea. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: observation.;Vomiting. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: observation.;Shivering. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: observation.;Blood pressure. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: mmHg.;Haert rate. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: beats/min.;Respiratory rate. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours -8 to 24 hours after intervention. Method of measurement: beats/min.;Arterial oxygen saturation. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours- 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: percent.;Drowsiness. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: Ramsey sedation score.;Headache. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: observation.;Allergic reaction. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: observation.;Arrythmia. Timepoint: 30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention. Method of measurement: observation.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamira - Kazem

Tehran University of Medical Science, School of Medicine

s_kazem@razi.tums.ac.ir+98 21 6640 0917

Outcome results

None listed

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