Anesthesia, SpinalNCT02961842
Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery
A study testing 500 mL Colloid Preload, Spinal Anesthesia and Intrathecal Bupivacaine in people with Anesthesia, Spinal and Cesarean Section, run by Mansoura University at 1 site in Egypt.
Trial summary
The study will compare one technique of fluid administration (combined colloid preload and crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery performed under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Anesthesia, Spinal, Cesarean Section
- What is being tested?
- 500 mL Colloid Preload, Spinal Anesthesia and Intrathecal Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2016to 9 Mar 2017
- 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status II parturients
- Full term, singleton pregnancy
- Elective cesarean delivery under spinal anesthesia
Who cannot join
- Age <19 or > 40 years
- Height <150 cm
- Weight <60 kg
- Body mass index ≥40 kg/m2
- Contraindications to spinal anesthesia (increased intracranial pressure, coagulopathy, or local skin infection)
- Chronic or pregnancy-induced hypertension
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- Hemoglobin <10 gm/dL.
- Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease
- Polyhydramnios or known fetal abnormalities
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511
About this study
The study will compare one technique of fluid administration (combined colloid preload and crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery performed under spinal anesthesia.
Read the detailed description
This randomized, controlled, double-blind study will be conducted on ASA physical status II parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Participants will receive either 500 mL colloid preload and 500 mL crystalloid coload (Combination group) or 1000 mL crystalloid coload (Coload group). Systolic blood pressure will be recorded every minute and ephedrine will be administered when hypotension occurs according to a predefined protocol. The total ephedrine dose, time to the first ephedrine dose, heart rate, inferior vena cava diameter, nausea/vomiting, and neonatal Apgar scores will be recorded.
- Conditions
- Anesthesia, Spinal, Cesarean Section
- Being tested
- 500 mL Colloid Preload, Spinal Anesthesia, Intrathecal Bupivacaine, Intrathecal Fentanyl, 500 mL Crystalloid Coload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500 mL Colloid PreloadDrug
6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 500 mL will be rapidly infused before spinal anesthesia
Spinal AnesthesiaProcedure or surgery
Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle
Intrathecal BupivacaineDrug
Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
Intrathecal FentanylDrug
Fentanyl 15 µg will be administered in the subarachnoid space
500 mL Crystalloid ColoadDrug
Ringer acetate 500 mL will be rapidly infused immediately after intrathecal injection
1000 mL Crystalloid ColoadDrug
Ringer acetate 1000 mL will be rapidly infused immediately after intrathecal injection
Cesarean DeliveryProcedure or surgery
Lower segment cesarean section using the Pfannenstiel incision
Ultrasound Assessment of the Inferior Vena CavaRadiation
The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 5-2 MHz curved array ultrasound probe placed longitudinally in the subxiphoid region
Intravenous EphedrineDrug
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Combination | Experimental | 500 mL colloid preload and 500 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Receives: Drug: 500 mL Colloid Preload; Procedure: Spinal Anesthesia; Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl; Drug: 500 mL Crystalloid Coload; Procedure: Cesarean Delivery; Radiation: Ultrasound Assessment of the Inferior Vena Cava; Drug: Intravenous Ephedrine |
| Coload | Active comparator | 1000 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. Receives: Procedure: Spinal Anesthesia; Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl; Drug: 1000 mL Crystalloid Coload; Procedure: Cesarean Delivery; Radiation: Ultrasound Assessment of the Inferior Vena Cava; Drug: Intravenous Ephedrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total ephedrine dose
Measured: intraoperative
Secondary outcomes (8)
Incidence of hypotension
Hypotension: Systolic blood pressure <80% of baseline
Measured: intraoperative
Incidence of severe hypotension
Severe hypotension: Systolic blood pressure <70% of baseline
Measured: intraoperative
Time to the first ephedrine dose
Measured: intraoperative
Heart rate
Measured: intraoperative
Inferior vena cava largest and smallest diameters
Measured: Baseline, at 1 and 5 minutes after intrathecal injection, delivery
Inferior vena cava collapsibility index
Collapsibility index = (Largest diameter - Smallest diameter) / Largest diameter
Measured: Baseline, at 1 and 5 minutes after intrathecal injection, delivery
Incidence of nausea and/or vomiting
Measured: intraoperative
Neonatal Apgar score
Measured: At 1 and 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start20 Nov 2016
- Primary completion9 Mar 2017
- Study completion9 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, SpinalStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mohamed Tawfik, Mansoura University
- Investigators
- Mohamed M Tawfik, MD, Principal investigator, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961842
- Sponsor's protocol ID
- R/16.09.64
- Status last verified
- Mar 2017
- First submitted
- 9 Nov 2016
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tawfik MM, Tarbay AI, Elaidy AM, Awad KA, Ezz HM, Tolba MA. Combined Colloid Preload and Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery: A Randomized Controlled Trial. Anesth Analg. 2019 Feb;128(2):304-312. doi: 10.1213/ANE.0000000000003306.
PubMed 29461392
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02961842
- Acronym / sponsor ID
- R/16.09.64
- Conditions
- Anesthesia, Spinal, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Nov 2016 (actual)
- Primary completion
- 9 Mar 2017 (actual)
- Study completion
- 9 Mar 2017 (actual)
- First posted
- 11 Nov 2016 (estimated)
- 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.
The study will compare one technique of fluid administration (combined colloid preload and crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery performed under spinal anesthesia.
Detailed description
This randomized, controlled, double-blind study will be conducted on ASA physical status II parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Participants will receive either 500 mL colloid preload and 500 mL crystalloid coload (Combination group) or 1000 mL crystalloid coload (Coload group). Systolic blood pressure will be recorded every minute and ephedrine will be administered when hypotension occurs according to a predefined protocol. The total ephedrine dose, time to the first ephedrine dose, heart rate, inferior vena cava diameter, nausea/vomiting, and neonatal Apgar scores will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination | Experimental | Drug: 500 mL Colloid Preload, Procedure: Spinal Anesthesia, Drug: Intrathecal Bupivacaine, Drug: Intrathecal Fentanyl, Drug: 500 mL Crystalloid Coload, Procedure: Cesarean Delivery, Radiation: Ultrasound Assessment of the Inferior Vena Cava, Drug: Intravenous Ephedrine500 mL colloid preload and 500 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. |
| Coload | Active comparator | Procedure: Spinal Anesthesia, Drug: Intrathecal Bupivacaine, Drug: Intrathecal Fentanyl, Drug: 1000 mL Crystalloid Coload, Procedure: Cesarean Delivery, Radiation: Ultrasound Assessment of the Inferior Vena Cava, Drug: Intravenous Ephedrine1000 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status II parturients
- Full term, singleton pregnancy
- Elective cesarean delivery under spinal anesthesia
Key exclusion criteria (9 listed)
- Age <19 or > 40 years
- Height <150 cm
- Weight <60 kg
- Body mass index ≥40 kg/m2
- Contraindications to spinal anesthesia (increased intracranial pressure, coagulopathy, or local skin infection)
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 |
|---|---|---|
| 500 mL Colloid Preload6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 500 mL will be rapidly infused before spinal anesthesia | Drug | Combination |
| Spinal AnesthesiaPerformed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle | Procedure or surgery | Coload, Combination |
| Intrathecal BupivacaineBupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space | Drug | Coload, Combination |
| Intrathecal FentanylFentanyl 15 µg will be administered in the subarachnoid space | Drug | Coload, Combination |
| 500 mL Crystalloid ColoadRinger acetate 500 mL will be rapidly infused immediately after intrathecal injection | Drug | Combination |
| 1000 mL Crystalloid ColoadRinger acetate 1000 mL will be rapidly infused immediately after intrathecal injection | Drug | Coload |
| Cesarean DeliveryLower segment cesarean section using the Pfannenstiel incision | Procedure or surgery | Coload, Combination |
| Ultrasound Assessment of the Inferior Vena CavaThe inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 5-2 MHz curved array ultrasound probe placed longitudinally in the subxiphoid region | Radiation | Coload, Combination |
| Intravenous EphedrineIntravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively. | Drug | Coload, Combination |
Primary outcome
Total ephedrine dose
Time frame: intraoperative
8 secondary outcomes
Incidence of hypotension
Time frame: intraoperative
Incidence of severe hypotension
Time frame: intraoperative
Time to the first ephedrine dose
Time frame: intraoperative
Heart rate
Time frame: intraoperative
Inferior vena cava largest and smallest diameters
Time frame: Baseline, at 1 and 5 minutes after intrathecal injection, delivery
Inferior vena cava collapsibility index
Time frame: Baseline, at 1 and 5 minutes after intrathecal injection, delivery
Incidence of nausea and/or vomiting
Time frame: intraoperative
Neonatal Apgar score
Time frame: At 1 and 5 minutes after delivery
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 22 Mar 2017.
- Derived from this study: PubMed 29461392Tawfik MM, Tarbay AI, Elaidy AM, Awad KA, Ezz HM, Tolba MA. Combined Colloid Preload and Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery: A Randomized Controlled Trial. Anesth Analg. 2019 Feb;128(2):304-312. doi: 10.1213/ANE.0000000000003306.
- Individual participant dataSharing planned: No
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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.
Mohamed M Tawfik, MD principal investigator
Mansoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 500 mL Colloid Preload, Spinal Anesthesia and Intrathecal Bupivacaine in people with Anesthesia, Spinal and Cesarean Section, run by Mansoura University at 1 site in Egypt.
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 3 inclusion and 9 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 22 Mar 2017. 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 Egypt. 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?
Total ephedrine dose (time frame: intraoperative). 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 NCT02961842, which also lists 1 linked publication.
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 22 Mar 2017; AzTrials last refreshed its copy on 29 Oct 2026.