Spinal AnaesthesiaNCT03681847
Crystalloids Versus Colloids Versus Hypertonic Saline as a Co-load During Spinal Anesthesia.
A study testing Normal saline, hydroxyethyl starch and Hypertonic saline in people with Spinal Anaesthesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Spinal anesthesia is commonly accompanied by hypotension due to vasodilation that follows sympathetic blockade and decreased systemic vascular resistance. Prevention of hypotension is usually achieved through administration of fluids and vasopressors .There is an ongoing debate concerning both the proper fluid timing… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Anaesthesia
- What is being tested?
- Normal saline, hydroxyethyl starch and Hypertonic saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2018to 30 Aug 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- ASA II-III
- Elective lower abdominal surgeries
Who cannot join
- Coagulation defects
- Abnormal kidney or liver functions
- Local infection at site of injection
- Uncontrolled hypertension
- Bone metastases
- Cardiac disease
- Elevated serum sodium level > 145 mEq/L
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia and Pain medicine.National Cancer Institute
Cairo, 11796
About this study
Official title: Crystalloids Versus Colloids Versus Hypertonic Saline Co-load During Spinal Anesthesia: Which is More Effective
Spinal anesthesia is commonly accompanied by hypotension due to vasodilation that follows sympathetic blockade and decreased systemic vascular resistance. Prevention of hypotension is usually achieved through administration of fluids and vasopressors .There is an ongoing debate concerning both the proper fluid timing, pre-load against co-load and fluid type crystalloids against colloids .This study aims at comparing the effectiveness of co-loading of crystalloids versus colloids versus hypertonic saline 3% in preventing hypotension induced by spinal anesthesia.
Read the detailed description
Spinal anesthesia is commonly accompanied by hypotension due to vasodilation that follows sympathetic blockade and decreased systemic vascular resistance. Prevention of hypotension is usually achieved through administration of fluids and vasopressors . Fluids are either administrated before initiation of spinal anesthesia which is defined as fluid pre-loading or at time of initiation of spinal anesthesia which is defined as fluid co-loading .There is an ongoing debate concerning both the proper fluid timing, pre-load against co-load and fluid type crystalloids against colloids. Fluid preloading with colloids appears to have superior effect on that of crystalloids as the later shows a shorter intravascular half-life. While both colloid and crystalloid co-loading show comparable results .Although crystalloid preloading has been the traditional regimen for long time, it failed to reduce the incidence of hypotension. This is because crystalloids rapidly distribute out of the intravascular compartment to the interstitial space. Superiority of fluid co-loading might be explained by decrease of the extravascular crystalloid redistribution secondary to the simultaneous vasodilatation response to sympathetic block.This study aims at comparing the effectiveness of co-loading of crystalloids versus colloids versus hypertonic saline 3% in preventing hypotension induced by spinal anesthesia.
- Conditions
- Spinal Anaesthesia
- Being tested
- Normal saline, hydroxyethyl starch, Hypertonic saline
- Keywords
- hypertonic saline, colloids, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineProcedure or surgery
normal saline 0.9% 15 ml/kg over 15-20 minutes.
hydroxyethyl starchProcedure or surgery
hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes.
Hypertonic salineProcedure or surgery
hypertonic saline 3% (7ml/kg) over 15-20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| normal saline | Active comparator | Patients will receive normal saline 0.9% 15 ml/kg over 15-20 minutes. Receives: Procedure: Normal saline |
| Hydroxyethyl starch | Active comparator | Patients will receive hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes. Receives: Procedure: hydroxyethyl starch |
| Hypertonic saline | Active comparator | Patients will receive hypertonic saline 3% (7ml/kg) over 15-20 minutes. Receives: Procedure: Hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
The development of hypotension
Measured: 3 hours
Secondary outcomes (1)
serum sodium level
measurement of serum sodium level
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start28 Feb 2018
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnaesthesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Hanafy Shaker, National Cancer Institute, Egypt
- Investigators
- Ehab H Shaker, MD, Principal investigator, National Cancer Institute- Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681847
- Sponsor's protocol ID
- Ehab-Walaa.Hypertonic
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: after finishing and publishing the study we plan to share it.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crystalloids Versus Colloids Versus Hypertonic Saline Co-load During Spinal Anesthesia: Which is More Effective
- ClinicalTrials.gov ID
- NCT03681847
- Acronym / sponsor ID
- Ehab-Walaa.Hypertonic
- Conditions
- Spinal Anaesthesia
- Keywords
- hypertonic saline, colloids, normal saline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 24 Sep 2018 (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.
Spinal anesthesia is commonly accompanied by hypotension due to vasodilation that follows sympathetic blockade and decreased systemic vascular resistance. Prevention of hypotension is usually achieved through administration of fluids and vasopressors .There is an ongoing debate concerning both the proper fluid timing, pre-load against co-load and fluid type crystalloids against colloids .This study aims at comparing the effectiveness of co-loading of crystalloids versus colloids versus hypertonic saline 3% in preventing hypotension induced by spinal anesthesia.
Detailed description
Spinal anesthesia is commonly accompanied by hypotension due to vasodilation that follows sympathetic blockade and decreased systemic vascular resistance. Prevention of hypotension is usually achieved through administration of fluids and vasopressors . Fluids are either administrated before initiation of spinal anesthesia which is defined as fluid pre-loading or at time of initiation of spinal anesthesia which is defined as fluid co-loading .There is an ongoing debate concerning both the proper fluid timing, pre-load against co-load and fluid type crystalloids against colloids. Fluid preloading with colloids appears to have superior effect on that of crystalloids as the later shows a shorter intravascular half-life. While both colloid and crystalloid co-loading show comparable results .Although crystalloid preloading has been the traditional regimen for long time, it failed to reduce the incidence of hypotension. This is because crystalloids rapidly distribute out of the intravascular compartment to the interstitial space. Superiority of fluid co-loading might be explained by decrease of the extravascular crystalloid redistribution secondary to the simultaneous vasodilatation response to sympathetic block.This study aims at comparing the effectiveness of co-loading of crystalloids versus colloids versus hypertonic saline 3% in preventing hypotension induced by spinal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal saline | Active comparator | Procedure: Normal salinePatients will receive normal saline 0.9% 15 ml/kg over 15-20 minutes. |
| Hydroxyethyl starch | Active comparator | Procedure: hydroxyethyl starchPatients will receive hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes. |
| Hypertonic saline | Active comparator | Procedure: Hypertonic salinePatients will receive hypertonic saline 3% (7ml/kg) over 15-20 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years
- ASA II-III
- Elective lower abdominal surgeries
Key exclusion criteria (7 listed)
- Coagulation defects
- Abnormal kidney or liver functions
- Local infection at site of injection
- Uncontrolled hypertension
- Bone metastases
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 |
|---|---|---|
| Normal salinenormal saline 0.9% 15 ml/kg over 15-20 minutes. | Procedure or surgery | normal saline |
| hydroxyethyl starchhydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes. | Procedure or surgery | Hydroxyethyl starch |
| Hypertonic salinehypertonic saline 3% (7ml/kg) over 15-20 minutes. | Procedure or surgery | Hypertonic saline |
Primary outcome
Hypotension
Time frame: 3 hours
The development of hypotension
1 secondary outcome
serum sodium level
Time frame: 3 hours
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 24 Sep 2018.
- Colloid versus Crystallid Co-load with Spinal Anesthesia during Emergent Cesarean Section and Their Effect on Hemodynamic Changes.Lotfy ME; Moustafa AM; Elham M.E, et al. J Am Sci 2014;10(11):158-163\]Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. after finishing and publishing the study we plan to share it.
Related trials for Spinal Anaesthesia
RecruitingPhase 4
Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
RecruitingObservational study
The Role of Preoperative Internal Jugular Vein Collapsibility and Perfusion Index in Predicting Hypotension After Spinal Anesthesia in Elective Cesarean Sections: A Prospective Observational Study
Postspinal Hypotension, Cesarean Birth
Not yet recruitingPhase 4
Remimazolam vs Propofol for Motor and Somatosensory Evoked Potentials in Spinal Tumor Surgery
Spinal Cord Neoplasms, Spinal Neoplasms
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
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.
Ehab H Shaker, MD principal investigator
National Cancer Institute- Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline, hydroxyethyl starch and Hypertonic saline in people with Spinal Anaesthesia, run by National Cancer Institute, Egypt 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 7 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 24 Sep 2018. 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?
Hypotension (time frame: 3 hours). 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 24 Sep 2018.