Shivering Caused by Spinal AnesthesiaNCT07663149
Effect of Continuous Phenylephrine Infusion on Preventing Shivering After Spinal Anesthesia in Cesarean Section
A study testing Phenylephrine in people with Shivering Caused by Spinal Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aims to evaluate the effectiveness of continuous phenylephrine infusion at 50 mcg/min in preventing shivering after spinal anesthesia in cesarean section. This study was an open-label randomized clinical trial involving patients undergoing cesarean section under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Shivering Caused by Spinal Anesthesia
- What is being tested?
- Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Apr 2026to 7 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females aged 18-50 years.
- Patients undergoing a Cesarean section procedure under spinal anesthesia.
- Patients who are not in labor (non-labor).
- Patients willing to participate in this study.
Who cannot join
- Patients with contraindications to phenylephrine.
- Patients with allergies to the study medications.
- Presence of fever (temperature >37.5°C) or hypothermia (temperature <35°C).
- American Society of Anesthesiologists (ASA) score of III or higher.
- Patients with a history of untreated thyroid disease.
- Patients with a history of autonomic nervous system neuropathy.
- Hypertension in pregnancy (or gestational hypertension).
- Body Mass Index (BMI) greater than 35 kg/m².
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUP dr. Cipto Mangunkusumo
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
This study aims to evaluate the effectiveness of continuous phenylephrine infusion at 50 mcg/min in preventing shivering after spinal anesthesia in cesarean section.
This study was an open-label randomized clinical trial involving patients undergoing cesarean section under spinal anesthesia. Subjects were allocated into two groups: without phenylephrine and continuous phenylephrine infusion at 50 mcg/min. The primary outcome was the incidence of shivering during observation, assessed using the Crossley and Mahajan scale. Secondary outcomes included hypotension, ephedrine requirement, hemodynamic adverse events, and nausea vomiting.
- Conditions
- Shivering Caused by Spinal Anesthesia
- Being tested
- Phenylephrine
- Keywords
- spinal anesthesia, phenylephrine, cesarean section, hypotension, shivering
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
giving phenylephrine continous infusion at rate 50 mcg/minutes intravenously after insertion of spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine group | Experimental | This group will be given an intervention of phenylephrine continous infusion at rate 50 mcg/min Receives: Drug: Phenylephrine |
| Without Phenylephrine group | No intervention | this group doesnt receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shivering
incidence of shivering after spinal anestesia intraoperatively
Measured: after the moment of spinal anesthesia until end of surgery
Secondary outcomes (1)
Hypotension
incidence of hypotension after spinal anesthesia, define as decreasing of more than 20% of blood pressure from baseline
Measured: after the moment of spinal anesthesia until end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start7 Apr 2026
- Primary completion7 Jun 2026
- Study completion7 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shivering Caused by Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfan Mahdi Nugroho, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663149
- Sponsor's protocol ID
- 26-01-0013
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Phenylephrine Infusion on Preventing Shivering After Spinal Anesthesia in Cesarean Section
- ClinicalTrials.gov ID
- NCT07663149
- Acronym / sponsor ID
- 26-01-0013
- Conditions
- Shivering Caused by Spinal Anesthesia
- Keywords
- spinal anesthesia, phenylephrine, cesarean section, hypotension, shivering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 7 Jun 2026 (actual)
- Study completion
- 7 Jun 2026 (actual)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of continuous phenylephrine infusion at 50 mcg/min in preventing shivering after spinal anesthesia in cesarean section.
This study was an open-label randomized clinical trial involving patients undergoing cesarean section under spinal anesthesia. Subjects were allocated into two groups: without phenylephrine and continuous phenylephrine infusion at 50 mcg/min. The primary outcome was the incidence of shivering during observation, assessed using the Crossley and Mahajan scale. Secondary outcomes included hypotension, ephedrine requirement, hemodynamic adverse events, and nausea vomiting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine group | Experimental | Drug: PhenylephrineThis group will be given an intervention of phenylephrine continous infusion at rate 50 mcg/min |
| Without Phenylephrine group | No intervention | –this group doesnt receive any intervention |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females aged 18-50 years.
- Patients undergoing a Cesarean section procedure under spinal anesthesia.
- Patients who are not in labor (non-labor).
- Patients willing to participate in this study.
Key exclusion criteria (8 listed)
- Patients with contraindications to phenylephrine.
- Patients with allergies to the study medications.
- Presence of fever (temperature >37.5°C) or hypothermia (temperature <35°C).
- American Society of Anesthesiologists (ASA) score of III or higher.
- Patients with a history of untreated thyroid disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenylephrinegiving phenylephrine continous infusion at rate 50 mcg/minutes intravenously after insertion of spinal anesthesia | Drug | Phenylephrine group |
Primary outcome
Shivering
Time frame: after the moment of spinal anesthesia until end of surgery
incidence of shivering after spinal anestesia intraoperatively
1 secondary outcome
Hypotension
Time frame: after the moment of spinal anesthesia until end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenylephrine in people with Shivering Caused by Spinal Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shivering (time frame: after the moment of spinal anesthesia until end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.