Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery

NCT02961842 | Completed

• 1 other identifier: R/16.09.64
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, Spinal; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Total ephedrine dose

  intraoperative

Secondary Outcomes (8)

• Incidence of hypotension

  intraoperative

• Incidence of severe hypotension

  intraoperative

• Time to the first ephedrine dose

  intraoperative

• Heart rate

  intraoperative

• Inferior vena cava largest and smallest diameters

  Baseline, at 1 and 5 minutes after intrathecal injection, delivery

Study Arms (2)

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.

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.

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

Interventions

500 mL Colloid Preload DRUG

6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 500 mL will be rapidly infused before spinal anesthesia

Combination

Spinal Anesthesia PROCEDURE

Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle

Coload; Combination

Intrathecal Bupivacaine DRUG

Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space

Coload; Combination

Intrathecal Fentanyl DRUG

Fentanyl 15 µg will be administered in the subarachnoid space

Coload; Combination

500 mL Crystalloid Coload DRUG

Ringer acetate 500 mL will be rapidly infused immediately after intrathecal injection

Combination

1000 mL Crystalloid Coload DRUG

Ringer acetate 1000 mL will be rapidly infused immediately after intrathecal injection

Coload

Cesarean Delivery PROCEDURE

Lower segment cesarean section using the Pfannenstiel incision

Coload; Combination

Ultrasound Assessment of the Inferior Vena Cava RADIATION

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

Coload; Combination

Intravenous Ephedrine DRUG

Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively.

Coload; Combination

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical status II parturients
• Full term, singleton pregnancy
• Elective cesarean delivery under spinal anesthesia

You may not qualify if:

• 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
• Hemoglobin \<10 gm/dL.
• Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease
• Polyhydramnios or known fetal abnormalities

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (1)

• 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.

  PMID: 29461392 DERIVED

MeSH Terms

Interventions

Anesthesia, Spinal; Cesarean Section

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mohamed M Tawfik, MD

  Mansoura University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of anesthesia and surgical intensive care, principal investigator

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 11, 2016
• Study Start: November 20, 2016
• Primary Completion: March 9, 2017
• Study Completion: March 9, 2017
• Last Updated: March 22, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)