Crystalloid Versus Colloid Rapid Co-load for Cesarean Delivery Under Spinal Anesthesia
Study Details
Study Description
Brief Summary
The study aims to compare crystalloid co-loading and colloid co-loading in parturients receiving prophylactic phenylephrine infusion during cesarean delivery in terms of the incidence of hypotension.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Crystalloid Patients will receive rapid co-load of plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia. |
Other: Crystalloid
Patients will receive the rapid co-loading with plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.
|
| Active Comparator: Colloid Patients will receive rapid co-load of 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia. |
Other: Colloid
Patients will receive the rapid co-loading with 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.
|
Outcome Measures
Primary Outcome Measures
- Incidence of maternal hypotension [during the time period from induction of spinal anesthesia until delivery]
defined as: Systolic Blood Pressure (SBP) < 80% of baseline SBP
Secondary Outcome Measures
- incidence of severe hypotension [during the time period from induction of spinal anesthesia until delivery]
defined as: Systolic Blood Pressure (SBP) < 70% of baseline SBP
- incidence of symptomatic hypotension [during the time period from induction of spinal anesthesia until delivery]
defined as: hypotension plus nausea and/or vomiting and/or dizziness and/or breathlessness
- incidence of bradycardia [during the time period from induction of spinal anesthesia until delivery]
Heart Rate (HR) <50 bpm
- incidence of Hypertension [during the time period from induction of spinal anesthesia until delivery]
Systolic Blood Pressure (SBP)> 120% of baseline SBP
- Minimum recorded Systolic Blood Pressure (Minimum SBP) [during the time period from induction of spinal anesthesia until delivery]
The lowest recorded SBP during the time period from induction of spinal anesthesia until delivery
- Minimum recorded Heart Rate (Minimum HR) [during the time period from induction of spinal anesthesia until delivery]
The lowest recorded HR during the time period from induction of spinal anesthesia until delivery
- Cumulative duration of hypotension [during the time period from induction of spinal anesthesia until delivery]
duration of hypotension, minutes
- Onset time of hypotension [during the time period from induction of spinal anesthesia until delivery]
Time from the induction of spinal anesthesia until the first event of hypotension occur
- Total phenylephrine use [during the time period from induction of spinal anesthesia until delivery]
Cumulative dose of phenylephrine administered via continuous infusion, mcg
- Rescue phenylephrine use [during the time period from induction of spinal anesthesia until delivery]
number of patients who require the rescue use of phenylephrine
- Rescue ephedrine use [during the time period from induction of spinal anesthesia until delivery]
number of patients who require the rescue use of ephedrine
- Atropine use [during the time period from induction of spinal anesthesia until delivery]
number of patients who require the rescue use of atropine
- Incidence of nausea, vomiting [during the time period from induction of spinal anesthesia until delivery]
The incidence of nausea, vomiting
- Incidence of dizziness, breathlessness [during the time period from induction of spinal anesthesia until delivery]
The incidence of dizziness, breathlessness
- Cutaneous stellate ganglion sympathetic activity [during the time period from induction of spinal anesthesia until delivery]
noninvasive recording of skin sympathetic nerve activity (SKNA) using conventional ECG electrodes
- Apgar Score, 1 min, 5 min (fetal outcome) [1 min, 5 min after delivery]
Apgar Score of delivered baby. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are the Appearance, Pulse, Grimace, Activity, and Respiration. Each is scored on a scale of 0 to 2, with 2 being the best score. The test is done at 1 and 5 minutes after birth.
- Umbilical arterial pH [immediately after delivery]
pH of Umbilical Arterial blood gas analysis (ABGA) (fetal outcome)
- Umbilical arterial base excess [immediately after delivery]
base excess of Umbilical ABGA (fetal outcome), mmol/L
- Umbilical arterial partial oxygen pressure (PO2) [immediately after delivery]
partial oxygen pressure of Umbilical ABGA (fetal outcome), mmHg
- Umbilical arterial carbon dioxide partial pressure (PCO2) [immediately after delivery]
carbon dioxide partial pressure of Umbilical ABGA (fetal outcome), mmHg
Eligibility Criteria
Criteria
Inclusion Criteria:
- Healthy, full-term parturients who scheduled to undergo elective cesarean delivery under spinal anesthesia.
Exclusion Criteria:
-
multiple pregnancy
-
gestational age < 36 weeks
-
preexisting or pregnancy-induced hypertension
-
Morbid cardiovascular impairments
-
Cerebrovascular disease
⑥ Known fetal anomaly
⑦ Contraindications to spinal anesthesia
⑧ Any sign of onset of labor
⑨ Body weight < 45 kg or body weight > 90 kg
⑩ Height < 145cm or height > 180cm
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
- Principal Investigator: Jin-Tae Kim, MD, PhD, Seoul National University Hospital, Seoul National University College of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- Doytchinova A, Hassel JL, Yuan Y, Lin H, Yin D, Adams D, Straka S, Wright K, Smith K, Wagner D, Shen C, Salanova V, Meshberger C, Chen LS, Kincaid JC, Coffey AC, Wu G, Li Y, Kovacs RJ, Everett TH 4th, Victor R, Cha YM, Lin SF, Chen PS. Simultaneous noninvasive recording of skin sympathetic nerve activity and electrocardiogram. Heart Rhythm. 2017 Jan;14(1):25-33. doi: 10.1016/j.hrthm.2016.09.019. Epub 2016 Sep 23.
- Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1.
- Ripollés Melchor J, Espinosa Á, Martínez Hurtado E, Casans Francés R, Navarro Pérez R, Abad Gurumeta A, Calvo Vecino JM. Colloids versus crystalloids in the prevention of hypotension induced by spinal anesthesia in elective cesarean section. A systematic review and meta-analysis. Minerva Anestesiol. 2015 Sep;81(9):1019-30. Epub 2014 Dec 11. Review.
- 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.
- H-1807-152-961