Postanesthetic ExcitementPhase 2NCT06289335
Dexmedetomidine Compared to Ondansetron for Postanaesthetic Shivering in Patients Undergoing a Cesarean Section
A Phase 2 study testing saline solution in people with Postanesthetic Excitement and Cesarean Section, run by Hospital Central "Dr. Ignacio Morones Prieto" at 1 site in Mexico.
Trial summary
Evaluate the efficiency of management with intravenous dexmedetomidine compared to intravenous ondansetron to achieve the disappearance of post-anesthetic shivering in a shorter time in the obstetric patient undergoing cesarean section under regional anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postanesthetic Excitement, Cesarean Section
- What is being tested?
- saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 5 Aug 2020to 3 Jan 2022
- Phase
- Phase 2
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA II or III, undergoing scheduled or emergency cesarean section with regional anesthesia (hyperbaric bupivacaine 0.5% with morphine at 1 mcg Kg-1) and who presented tremor grade >1 based on the BSAS scale
Who cannot join
- Hemodynamic instability, heart disease or sinus bradycardia, allergy to any of the medications applied, psychiatric diseases or hypothermia <35.2 ºC measured by tympanic temperature.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosí City, 78290
About this study
Official title: Dexmedetomidine Compared With Ondansetron in Treating Postanesthetic Shivering in Patients After Regional Anesthesia for Cesarean Section-a Randomized Clinical Trial.
Evaluate the efficiency of management with intravenous dexmedetomidine compared to intravenous ondansetron to achieve the disappearance of post-anesthetic shivering in a shorter time in the obstetric patient undergoing cesarean section under regional anesthesia.
Read the detailed description
Randomized clinical trial with 40 pregnant patients, between 18 and 45 years old with ASA (American Society of Anesthesiologist) II or III, undergoing scheduled or emergency cesarean section with regional anesthesia and who presented grade tremor 1 based on the BSAS (Bedside shivering assessment scale) scale, at the Hospital Central from San Luis Potosi, Mexico. The main objective of this study was to quantify the time that elapsed from the end of the administration of the medication until the disappearance of the tremor, which was measured in minutes; The evaluation of the disappearance, persistence or reappearance of the tremor was solely visual by the anesthesiology staff.
- Conditions
- Postanesthetic Excitement, Cesarean Section
- Being tested
- saline solution
- Keywords
- shivering, dexmedetomidine, ondansetron, regional anesthesia
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saline solutionDrug
Also called isotonic solution
20 mL of saline
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | 0.3 mcg Kg-1 (actual weight) of dexmedetomidine IV in 20 mL of saline Receives: Drug: saline solution |
| Ondansetron | Sham comparator | 8 mg ondansetron IV in 20 mL saline Receives: Drug: saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period of time
period of time in which post-anesthetic tremor is controlled from the moment of administration
Measured: one hour
Secondary outcomes (1)
Adverse effects
To measure the frequencies of occurrence of adverse effects and changes in vital signs (heart rate, blood pressure, and temperature [measured at the tympanic membrane]) correlated with resolution of tremor.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start5 Aug 2020
- Primary completion5 Sep 2021
- Study completion3 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Postanesthetic ExcitementStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIO AURELIO MARTÍNEZ-JIMÉNEZ, Hospital Central "Dr. Ignacio Morones Prieto"
- Investigators
- MARIO A MARTÍNEZ-JIMÉNEZ, Dr., Study director, Hospital Central "Dr. Ignacio Morones Prieto"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289335
- Sponsor's protocol ID
- HCDrIMPrieto anaesthesia
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It might be useful for other researchers to expand their investigations, nevertheless, in this moment it seems completed this branch of investigation.
Publications
Lopez MB. Postanaesthetic shivering - from pathophysiology to prevention. Rom J Anaesth Intensive Care. 2018 Apr;25(1):73-81. doi: 10.21454/rjaic.7518.251.xum.
PubMed 29756066Jain A, Gray M, Slisz S, Haymore J, Badjatia N, Kulstad E. Shivering Treatments for Targeted Temperature Management: A Review. J Neurosci Nurs. 2018 Apr;50(2):63-67. doi: 10.1097/JNN.0000000000000340.
PubMed 29278601Tsai YC, Chu KS. A comparison of tramadol, amitriptyline, and meperidine for postepidural anesthetic shivering in parturients. Anesth Analg. 2001 Nov;93(5):1288-92. doi: 10.1097/00000539-200111000-00052.
PubMed 11682416Talke P, Tayefeh F, Sessler DI, Jeffrey R, Noursalehi M, Richardson C. Dexmedetomidine does not alter the sweating threshold, but comparably and linearly decreases the vasoconstriction and shivering thresholds. Anesthesiology. 1997 Oct;87(4):835-41. doi: 10.1097/00000542-199710000-00017.
PubMed 9357885Elvan EG, Oc B, Uzun S, Karabulut E, Coskun F, Aypar U. Dexmedetomidine and postoperative shivering in patients undergoing elective abdominal hysterectomy. Eur J Anaesthesiol. 2008 May;25(5):357-64. doi: 10.1017/S0265021507003110. Epub 2008 Jan 21.
PubMed 18205960Hoffman J, Hamner C. Effectiveness of dexmedetomidine use in general anesthesia to prevent postoperative shivering: a systematic review. JBI Database System Rev Implement Rep. 2016 Jan 15;13(12):287-313. doi: 10.11124/jbisrir-2015-2257.
PubMed 26767820Yu G, Jin S, Chen J, Yao W, Song X. The effects of novel alpha2-adrenoreceptor agonist dexmedetomidine on shivering in patients underwent caesarean section. Biosci Rep. 2019 Feb 1;39(2):BSR20181847. doi: 10.1042/BSR20181847. Print 2019 Feb 28.
PubMed 30643009Abdel-Ghaffar HS, Mohamed SA, Fares KM, Osman MA. Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial. Pain Physician. 2016 May;19(4):243-53.
PubMed 27228512He K, Zhao H, Zhou HC. Efficiency and safety of ondansetron in preventing postanaesthesia shivering. Ann R Coll Surg Engl. 2016 Jul;98(6):358-66. doi: 10.1308/rcsann.2016.0152. Epub 2016 May 3.
PubMed 27138855Nallam SR, Cherukuru K, Sateesh G. Efficacy of Intravenous Ondansetron for Prevention of Postspinal Shivering during Lower Segment Cesarean Section: A Double-Blinded Randomized Trial. Anesth Essays Res. 2017 Apr-Jun;11(2):508-513. doi: 10.4103/aer.AER_26_17.
PubMed 28663651Botros JM, Mahmoud AMS, Ragab SG, Ahmed MAA, Roushdy HMS, Yassin HM, Bolus ML, Goda AS. Comparative study between Dexmedetomidine and Ondansteron for prevention of post spinal shivering. A randomized controlled trial. BMC Anesthesiol. 2018 Nov 30;18(1):179. doi: 10.1186/s12871-018-0640-3.
PubMed 30501612
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Compared With Ondansetron in Treating Postanesthetic Shivering in Patients After Regional Anesthesia for Cesarean Section-a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06289335
- Acronym / sponsor ID
- HCDrIMPrieto anaesthesia
- Conditions
- Postanesthetic Excitement, Cesarean Section
- Keywords
- shivering, dexmedetomidine, ondansetron, regional anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"University, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 1 Mar 2024 (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.
Evaluate the efficiency of management with intravenous dexmedetomidine compared to intravenous ondansetron to achieve the disappearance of post-anesthetic shivering in a shorter time in the obstetric patient undergoing cesarean section under regional anesthesia.
Detailed description
Randomized clinical trial with 40 pregnant patients, between 18 and 45 years old with ASA (American Society of Anesthesiologist) II or III, undergoing scheduled or emergency cesarean section with regional anesthesia and who presented grade tremor 1 based on the BSAS (Bedside shivering assessment scale) scale, at the Hospital Central from San Luis Potosi, Mexico. The main objective of this study was to quantify the time that elapsed from the end of the administration of the medication until the disappearance of the tremor, which was measured in minutes; The evaluation of the disappearance, persistence or reappearance of the tremor was solely visual by the anesthesiology staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: saline solution0.3 mcg Kg-1 (actual weight) of dexmedetomidine IV in 20 mL of saline |
| Ondansetron | Sham comparator | Drug: saline solution8 mg ondansetron IV in 20 mL saline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA II or III, undergoing scheduled or emergency cesarean section with regional anesthesia (hyperbaric bupivacaine 0.5% with morphine at 1 mcg Kg-1) and who presented tremor grade >1 based on the BSAS scale
Key exclusion criteria (1 listed)
- Hemodynamic instability, heart disease or sinus bradycardia, allergy to any of the medications applied, psychiatric diseases or hypothermia <35.2 ºC measured by tympanic temperature.
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 |
|---|---|---|
| saline solutionAlso: isotonic solution20 mL of saline | Drug | Dexmedetomidine, Ondansetron |
Primary outcome
Period of time
Time frame: one hour
period of time in which post-anesthetic tremor is controlled from the moment of administration
1 secondary outcome
Adverse effects
Time frame: one hour
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 1 Mar 2024.
- Background: PubMed 29756066Lopez MB. Postanaesthetic shivering - from pathophysiology to prevention. Rom J Anaesth Intensive Care. 2018 Apr;25(1):73-81. doi: 10.21454/rjaic.7518.251.xum.
- Background: PubMed 29278601Jain A, Gray M, Slisz S, Haymore J, Badjatia N, Kulstad E. Shivering Treatments for Targeted Temperature Management: A Review. J Neurosci Nurs. 2018 Apr;50(2):63-67. doi: 10.1097/JNN.0000000000000340.
- Background: PubMed 11682416Tsai YC, Chu KS. A comparison of tramadol, amitriptyline, and meperidine for postepidural anesthetic shivering in parturients. Anesth Analg. 2001 Nov;93(5):1288-92. doi: 10.1097/00000539-200111000-00052.
- Background: PubMed 9357885Talke P, Tayefeh F, Sessler DI, Jeffrey R, Noursalehi M, Richardson C. Dexmedetomidine does not alter the sweating threshold, but comparably and linearly decreases the vasoconstriction and shivering thresholds. Anesthesiology. 1997 Oct;87(4):835-41. doi: 10.1097/00000542-199710000-00017.
- Background: PubMed 18205960Elvan EG, Oc B, Uzun S, Karabulut E, Coskun F, Aypar U. Dexmedetomidine and postoperative shivering in patients undergoing elective abdominal hysterectomy. Eur J Anaesthesiol. 2008 May;25(5):357-64. doi: 10.1017/S0265021507003110. Epub 2008 Jan 21.
- Results publication: PubMed 26767820Hoffman J, Hamner C. Effectiveness of dexmedetomidine use in general anesthesia to prevent postoperative shivering: a systematic review. JBI Database System Rev Implement Rep. 2016 Jan 15;13(12):287-313. doi: 10.11124/jbisrir-2015-2257.
- Results publication: PubMed 30643009Yu G, Jin S, Chen J, Yao W, Song X. The effects of novel alpha2-adrenoreceptor agonist dexmedetomidine on shivering in patients underwent caesarean section. Biosci Rep. 2019 Feb 1;39(2):BSR20181847. doi: 10.1042/BSR20181847. Print 2019 Feb 28.
- Results publication: PubMed 27228512Abdel-Ghaffar HS, Mohamed SA, Fares KM, Osman MA. Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial. Pain Physician. 2016 May;19(4):243-53.
- Results publication: PubMed 27138855He K, Zhao H, Zhou HC. Efficiency and safety of ondansetron in preventing postanaesthesia shivering. Ann R Coll Surg Engl. 2016 Jul;98(6):358-66. doi: 10.1308/rcsann.2016.0152. Epub 2016 May 3.
- Results publication: PubMed 28663651Nallam SR, Cherukuru K, Sateesh G. Efficacy of Intravenous Ondansetron for Prevention of Postspinal Shivering during Lower Segment Cesarean Section: A Double-Blinded Randomized Trial. Anesth Essays Res. 2017 Apr-Jun;11(2):508-513. doi: 10.4103/aer.AER_26_17.
- Results publication: PubMed 30501612Botros JM, Mahmoud AMS, Ragab SG, Ahmed MAA, Roushdy HMS, Yassin HM, Bolus ML, Goda AS. Comparative study between Dexmedetomidine and Ondansteron for prevention of post spinal shivering. A randomized controlled trial. BMC Anesthesiol. 2018 Nov 30;18(1):179. doi: 10.1186/s12871-018-0640-3.
- Individual participant dataSharing planned: No. It might be useful for other researchers to expand their investigations, nevertheless, in this moment it seems completed this branch of investigation.
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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.
MARIO A MARTÍNEZ-JIMÉNEZ, Dr. study director
Hospital Central "Dr. Ignacio Morones Prieto"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing saline solution in people with Postanesthetic Excitement and Cesarean Section, run by Hospital Central "Dr. Ignacio Morones Prieto" at 1 site in Mexico.
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 1 inclusion and 1 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 1 Mar 2024. 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 Mexico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Period of time (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06289335, which also lists 11 linked publications.
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 1 Mar 2024.