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Evaluation of intrathecal dexmedetomidine effect on core body temperature and shivering during spinal anesthesia for cesarean section

Evaluation of intrathecal dexmedetomidine effect on core body temperature and shivering during spinal anesthesia for cesarean section

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201511301766N7
Enrollment
50
Registered
2016-01-12
Start date
2015-12-22
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

Spinal Anesthesia. other complication of spinal and epidural anesthesia during pregnancy

Interventions

Intervention 1: Intervention : 5 microgram Dexmedetomidine will be added to 12.5 Mg bupivacaine 0.5% and 0.49 mi 0.9% normal saline (total volume 3 ML) for injection to spinal space in L3-L4 or L4-L5
Treatment - Drugs
Placebo
Intervention : 5 microgram Dexmedetomidine will be added to 12.5 Mg bupivacaine 0.5% and 0.49 mi 0.9% normal saline (total volume 3 ML) for injection to spinal space in L3-L4 or L4-L5 level via 25G ne
Control : 12.5 Mg bupivacaine 0.5% will be added to 0.5 ML 0.9% normal saline (total volume =3 ML) for injection to spinal space in L3-L4 or L4-L5 level via 25G needle .

Sponsors

Kurdistan University of Medical Sciences .Vice chancellor for research
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria :Filling informed consent form of study by patients ; American society of anesthesiologist physical status I or II Exclusion criteria :any absolute or relative contraindication for spinal anesthesia ; core body temperature more than 37.5 or lower than 36.5 °C ; BMI>25 ; cardiac block or dysrhythmia ; history of Psychiatric disease ; history of taking a receptor antagonist drugs ; history of hypertension or taking any antihypertensive drug ; history of any cardiac disease ( ischemic , valvular , block ) ; history of renal failure ; history of hepatic failure ; history of allergy to study drugs ; failure or incomplete spinal block ; excessive hemorrhage that need transfusion

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Core body tempreture. Timepoint: 5 Minute. Method of measurement: with termoscan via tempanic membrane.;Shivering. Timepoint: Continuse. Method of measurement: Yes/No.

Secondary

MeasureTime frame
Grade of Shivering. Timepoint: continuse. Method of measurement: zero = no shivering, 1 = shivering in face or neck, 2 = muscular activity in more than one muscle group, but not generalized; and 3 = shivering involving the whole body.;The time from spinal anesthesia to bigning of shevering. Timepoint: continuse. Method of measurement: The time interval from spinal anesthesia to bigning of shevering.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Ebrahim Ghaderi

Sanandaj Faculty of Medicine

ebrahimghaderi@muk.ac.ir+98 87 3366 6473

Outcome results

None listed

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