Skip to content

Clonidine Versus Granisetron for Shivering Prevension

Intravenous Clonidine Versus Granisetron for Prevention of Post Spinal Anesthesia Shivering in Cesarean Section

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06031090
Enrollment
186
Registered
2023-09-11
Start date
2023-03-05
Completion date
2023-10-30
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Spinal Anesthesia Shivering

Brief summary

Prevention of post spinal anesthesia shivering during cesarean section with its associated discomfort, distress, aggravation of pain, increased metabolic demands, and increased oxygen consumption

Detailed description

Shivering is one of the most important periperative complications seen in clinical practice. Several mechanisms have been postulated for its pathogenesis. Anesthetic-induced inhibition of thermoregulation resulting in hypothermia is an important cause of post anesthesia shivering, uncontrolled spinal reflexes, and cutaneous vasodilation are the other suggested mechanisms involved in the pathogenesis of shivering. Opioid receptors, α2 receptors, and serotonergic receptors also are involved of shivering. Various drugs were studied for their potential role in prevention of peri-operative shivering such as tramadol, dexmedetomidine, ondansetron, ketamine, and pethidine. We decided to perform a well-designed study to compare clonidine and granisetron which has been recently introduced as drugs for prevention and control of shivering after spinal anesthesia.

Interventions

intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia

intravenous 1mg of granisetron diluted in 10ml normal saline 20 minutes before spinal anesthesia.

intravenous 10 ml normal saline 20 minutes before spinal anesthesia

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

triple blinded

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

Patient acceptance.,Aged between 21-40 years old, BMI: 18- 30 kg/m2, ASA: I and II., Scheduled for elective cesarean section under spinal anesthesia. \-

Exclusion criteria

History of hypersensitivity to drugs used in this study,Patients with history of chronic pain and taking analgesics, Patients with sepsis and Significant cardiac, liver or renal diseases, Uncooperative patients or with psychiatric disorders that prevent surgery under spinal anesthesia, Atrio-ventricular block in any degree, cardiac arrhythmias, valvular heart disease, kidney or liver diseases, neuromuscular disorders and diabetes mellitus \-

Design outcomes

Primary

MeasureTime frameDescription
Incidence of ShiveringProcedure (through out the period of spinal anesthesia)• Shivering will be graded according to Tsai and Chu scale (10): 0 = no shivering, 1 = piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 =shivering involving the whole body

Secondary

MeasureTime frameDescription
core body temperatureProcedure (preoperative as base and through out the period of spinal anesthesia)Core body temperature was detected by measuring tympanic membrane temperature using digital infrared ear thermometer (thermoscan KFT-10; Grnzia, genova, Italy).
Maternal Heart rateProcedure (preoperative as base and through out the period of spinal anesthesia)beats/minute
baby APGAR score1 minutes and 5 minutes post natal
maternal blood presureProcedure (preoperative as base and through out the period of spinal anesthesia)mmhg

Other

MeasureTime frame
maternal oxygen saturationProcedure (preoperative as base and through out the period of spinal anesthesia)

Countries

Egypt

Contacts

Primary ContactHeba M Fathi, M.D
heba_elgendi@yahoo.com00201000143938

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026