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Trial registered on ANZCTR


Registration number
ACTRN12615000575538
Ethics application status
Approved
Date submitted
31/03/2015
Date registered
3/06/2015
Date last updated
3/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The hemodynamic effects of Combined Epinephrine and Clonidine added to intrathecal Bupivacaine in cesarean section
Scientific title
Evaluation of hemodynamic effects of Combined Epinephrine and Clonidine added to intrathecal Bupivacaine , in patients undergoing cesarean section


Secondary ID [1] 286266 0
nil
Universal Trial Number (UTN)
U1111-1167-5121
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemodynamic changes in cesarean section patients 294326 0
Condition category
Condition code
Anaesthesiology 294646 294646 0 0
Anaesthetics
Reproductive Health and Childbirth 295193 295193 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ninety patients 18-40 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups.The Clonidine group (group C) received bupivacaine 10 mg combined with 75 microgramg Clonidine preservative free solution ,The Epinephrin-Clonidin group (group E-C) received bupivacaine 10mg combined with 35 microgramg Clonidin and 200 microgram Epinephrin. The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water(intrathecally) for each three groups 5 minutes prior to surgery.
Intervention code [1] 291406 0
Treatment: Drugs
Intervention code [2] 291407 0
Prevention
Comparator / control treatment
The placebo group (group P) received bupivacaine 10mg combined with 0.5 ml distilled water
Control group
Placebo

Outcomes
Primary outcome [1] 294544 0
Assesment of the changes in mean blood pressure (MBP) (this variable was measured by Automatic digital non-invasive blood pressure)
Timepoint [1] 294544 0
5min before the spinal injection,and at 2, 4, 6, 10, 15,20 ,25,30 min after the injection
Primary outcome [2] 294545 0
Heart rate was assessed by echocardiogram monitoring
Timepoint [2] 294545 0
5min before the spinal injection,and at 2, 4, 6, 10, 15,20 ,25,30 min after the injection
Secondary outcome [1] 313594 0
Sensory block onset time was be assessed by a pinprick test
Timepoint [1] 313594 0
The onset of sensory block was defined as the time between the end of injection of the spinal anesthetic and the absence of pain at the T10 dermatome(sensory block will be assessed by pinprick test every 10 seconds following spinal injection)
Secondary outcome [2] 313595 0
Duration of sensory block will be assessed by a pinprick test
Timepoint [2] 313595 0
The time for regression from the maximum block height((sensory block to T10 dermatom will be assessed by pinprick test every 5 minuts following spinal injection)
Secondary outcome [3] 313596 0
The onset of motor block will be assessed by the modified Bromage score (0, no motor loss; 1, inability to flex the hip; 2, inability to flex the knee; and 3, inability to flex the ankle)
Timepoint [3] 313596 0
The time from spinal injection to Bromage1 block 1(motor block will be assessed by pinprick test every 10 seconds following spinal injection)
Secondary outcome [4] 313597 0
Duration of motor block (the time from spinal injection to Bromage score 0) will be assessed by the modified Bromage score (0, no motor loss; 1, inability to flex the hip; 2, inability to flex the knee; and 3, inability to flex the ankle)
Timepoint [4] 313597 0
The time from spinal injection to Bromage score 0(motor block will be assessed by the modified Bromage score every 5 minuts following spinal injection)
Secondary outcome [5] 314492 0
neonate's APGAR 1 & 5 minute
Timepoint [5] 314492 0
APGAR Scoring at 1 & 5 minute after birth ( based on "Virginia Apgar" Score)
Secondary outcome [6] 315102 0
Time to first requirement of analgesic supplement(analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)
Timepoint [6] 315102 0
Time to first requirement of analgesic supplement from the time of injection intrathecal anesthetic solution

Eligibility
Key inclusion criteria
Patients with American Society of Anesthesiologists(ASA) physical status I and II, undergoing elective cesarean section under spinal anesthesia
Minimum age
18 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Significant coexisting disease such as hepatic,renal and cardiovascular disease, any contraindication to regional anesthesia such as local infection or bleeding disorders, allergy to clonidine , long-term opioid use or a history of chronic hypertension , preeclampsia , eclampsia,fetal distress

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)
Enrollment is decided and permission of the patient is obtained by the anesthesiologists during preoperative rounding.This is a double blinded clinical trial, with blinding of both the patient and the administrating practitioner to the anaesthetic type. Allocation will be managed by a Resident external to the project. The blinding will occur through use of equal amounts of pretreatment drugs (3ml’s) Each syringe will be labeled A ,B,C according to its contents. . The drug syringes are handed over to anesthesiologists blinded to the patient allocation to carry out the spinal of anesthesia
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was based on computer-generated codes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
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] 6755 0
Iran, Islamic Republic Of
State/province [1] 6755 0
Qazvin

Funding & Sponsors
Funding source category [1] 290938 0
Self funded/Unfunded
Name [1] 290938 0
Marzieh Khezri
Address [1] 290938 0
Marzieh Beigom Khezri, , Department of Anesthesiology ,Qazvin University of Medical Sciences. Iran ,Qazvin -Bahonar Blvd.
postal code:34188 99578
Country [1] 290938 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Qazvin Medical Science University
Address
Shahid bahonar,Ave,Qazvin ,Iran
postal code:34197/59811
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 289623 0
Hospital
Name [1] 289623 0
Kosar Hospital
Address [1] 289623 0
Taleghani street,Qazvin,Iran
postal code:3413996134
Country [1] 289623 0
Iran, Islamic Republic Of
Other collaborator category [1] 278396 0
Individual
Name [1] 278396 0
Nahid Nasseh
Address [1] 278396 0
Department of Anesthesiology ,,Qazvin University of Medical Sciences ,shahid bahonar,Ave, Qazvin ,Iran
postal code:34197/59811
Country [1] 278396 0
Iran, Islamic Republic Of
Other collaborator category [2] 278397 0
Individual
Name [2] 278397 0
Abolghasem Ahmadvand
Address [2] 278397 0
Resident of Anesthesiology,Qazvin University of Medical Sciences ,shahid bahonar,Ave, Qazvin ,Iran
postal code:34197/59811
Country [2] 278397 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Objective :To compare the hemodynamic effects of combined intrathecal Clonidine and Epinephrin as an additive to bupivacaine in patients undergoing cesarean section .
Methods:Following Ethics Committee approval and informed patients consent, Ninety patients 18-40 yr old ASA physical status I or II, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups. The Clonidine group (groupC) received bupivacaine 10mg combined with 75 microgram clonidine preservative free ,the Epinephrin-Clonidin group (group E-C) received bupivacaine 10mg combined with 35 microgram Clonidin and 200 microgram Epinephrin, and the placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .Intraoperative changes in hemodynamics variables [Mean Blood pressuer(MBP) and Heart Rate( HR)], Sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, the incidence of hypotension, ephedrine requirements, bradycardia , neonate's APGAR 1 & 5 minute were recorded. MBP was measured and monitored by automated non-invasive blood pressure in arm and HR was recorded by Electrocardiogram(ECG).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55230 0
Dr Marzieh Beigom Khezri
Address 55230 0
Marzieh Beigom Khezri, Department of Anesthesiology ,Qazvin University of Medical Sciences. Iran ,Qazvin - Bahonar Blvd.
postal code:3419759811
Country 55230 0
Iran, Islamic Republic Of
Phone 55230 0
+98-28-33222951
Fax 55230 0
+98-28-33236378
Email 55230 0
mkhezri@qums.ac.ir
Contact person for public queries
Name 55231 0
Dr Marzieh Beigom Khezri
Address 55231 0
Marzieh Beigom Khezri, Department of Anesthesiology ,Qazvin University of Medical Sciences. Iran ,Qazvin -Bahonar Blvd.
postal code:3419759811
Country 55231 0
Iran, Islamic Republic Of
Phone 55231 0
+98-28-33222951
Fax 55231 0
+98-28-33236378
Email 55231 0
mkhezri@qums.ac.ir
Contact person for scientific queries
Name 55232 0
Dr Nahid Nasseh
Address 55232 0
Nahid Nasseh, Department of Anesthesiology ,Qazvin University of Medical Sciences. Iran ,Qazvin - Bahonar Blvd.
postal code:3419759811
Country 55232 0
Iran, Islamic Republic Of
Phone 55232 0
+98-28-33328627
Fax 55232 0
+98-28-33236378
Email 55232 0
nahid.nasseh@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary