ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611001059954

Ethics application status

Approved

Date submitted

10/10/2011

Date registered

11/10/2011

Date last updated

11/10/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

Granisetron and incidence of shivering in children after spinal anesthesia

Scientific title

Premedication with Granisetron prevents shivering during spinal anaesthesia in children

Secondary ID [1]

'Nil'

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

shivering during spinal anesthesia in children

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Effect of Premedication with Granisetron on incidence of shivering during spinal anesthesia in children
intravenous 10 mcg/Kg granisetron diluted in 10 ml saline 0.9% to be given over 5 minutes just before spinal puncture.
Spinal block was done by intrathecal hyperbaric bupivacine 0.5% (0.5 mg/Kg).

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

Intravenous 10 ml 0.9% saline to be given over 5 minutes just before spinal puncture.

Control group

Placebo

Outcomes

Primary outcome [1]

Incidence of shivering
Shivering was assessed using scale of Tsai and Chu.
0 no shivering
1 Mild fasciculations of face or neck
2 Visible tremor involving more than one muscle group
3 Gross muscular activity involving the entire body

Timepoint [1]

shivering were recorded before spinal anesthesia, 15, 30, 60& 90 min. after spinal anesthesia.

Secondary outcome [1]

Motor block was assessed using the Bromage scale recording the ability to flex hip, knee and ankle.

Timepoint [1]

10 minute after injection of bupivacaine

Secondary outcome [2]

Sensory block was assessed by bilateral pin prick at each dermatome to elicit grimace or acknowledgement of pain.

Timepoint [2]

10 minute after injection of bupivacaine

Eligibility

Key inclusion criteria

80 children ASA 1 and 2 scheduled for lower limb surgery under spinal anaesthesia were entered into study

Minimum age

2 Years

Maximum age

5 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria included: refusal of parents, coagulopathy, spinal congenital anomalies, neurological abnormality, allergy to local anesthetics and surgery scheduled to last for more than 90 minutes, children with hypo or hyperthyroidism, children with hypothermia or hyperthermia and those who needed intraoperative blood transfusion.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomization was performed using a computer based random number generator in permutated blocks of varying sizes and the assignment entered in sealed envelopes that were not opened till informed consent was obtained. The drug was mixed and administered by a nurse who took no further part in the study. The patient, parent, anesthesiologist, observer gathering data and nurses taking care of the patient in the preoperative period remained blinded to the group assignment.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/2011

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Egypt

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Yasser M. Amr

Address

Anesthesia department- Tanta university hospitals- Tanta university
El- Geish street
Postal Code: 31257
Tanta- Egypt

Country

Egypt

Secondary sponsor category [1]

Individual

Name [1]

Ahmed A. Eldaba

Address [1]

Anesthesia department- Tanta university hospitals- Tanta university
El- Geish street
Postal Code: 31257
Tanta- Egypt

Country [1]

Egypt

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Faculty of medicine- Tanta university

Ethics committee address [1]

Anesthesia department- Tanta university hospitals- Tanta university 
El- Geish street
Postal Code:  31257 
Tanta- Egypt

Ethics committee country [1]

Egypt

Date submitted for ethics approval [1]

02/02/2011

Approval date [1]

02/03/2011

Ethics approval number [1]

Summary

Brief summary

80 children  aged from 2-5 years scheduled for surgery in lower limb were prepared for spinal anesthesia. Children were classified into two groups, Group 1 (40 children) received intravenous 10 mcg/Kg granisetron diluted in 10 ml saline 0.9% and Group 2 (40 children) received intravenous 10 ml 0.9% saline to be given over 5 minutes just before spinal puncture. Shivering, core temperature levels of motor and sensory block were assessed.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Yasser M. Amr

Address

Anesthesia department- Tanta university hospitals- Tanta university
El- Geish street
Postal Code: 31257
Tanta- Egypt

Country

Egypt

Phone

201224462887

Fax

[email protected]

Contact person for scientific queries

Name

Yasser M. Amr

Address

Anesthesia department- Tanta university hospitals- Tanta university
El- Geish street
Postal Code: 31257
Tanta- Egypt

Country

Egypt

Phone

201224462887

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Premedication with Granisetron Reduces Shivering during Spinal Anaesthesia in Children	2012	https://doi.org/10.1177/0310057x1204000118

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically