Crystalloids Versus Colloids Versus Hypertonic Saline as a Co-load During Spinal Anesthesia.

NCT03681847 | Completed

• 1 other identifier: Ehab-Walaa.Hypertonic
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Spinal Anaesthesia

Keywords

hypertonic saline; colloids; normal saline

Outcome Measures

Primary Outcomes (1)

• Hypotension

  The development of hypotension

  3 hours

Secondary Outcomes (1)

• serum sodium level

  3 hours

Study Arms (3)

normal saline

ACTIVE COMPARATOR

Patients will receive normal saline 0.9% 15 ml/kg over 15-20 minutes.

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.

Procedure: hydroxyethyl starch

Hypertonic saline

ACTIVE COMPARATOR

Patients will receive hypertonic saline 3% (7ml/kg) over 15-20 minutes.

Procedure: Hypertonic saline

Interventions

Normal saline PROCEDURE

normal saline 0.9% 15 ml/kg over 15-20 minutes.

normal saline

hydroxyethyl starch PROCEDURE

hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes.

Hydroxyethyl starch

Hypertonic saline PROCEDURE

hypertonic saline 3% (7ml/kg) over 15-20 minutes.

Hypertonic saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• ASA II-III
• Elective lower abdominal surgeries

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Department of Anesthesia and Pain medicine.National Cancer Institute

Cairo, 11796, Egypt

Location

Related Links

• 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\]

MeSH Terms

Interventions

Saline Solution; Hydroxyethyl Starch Derivatives; Saline Solution, Hypertonic

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides; Hypertonic Solutions

Study Officials

• Ehab H Shaker, MD

  National Cancer Institute- Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia ,critical care and pain medicine

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 24, 2018
• Study Start: February 28, 2018
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: September 24, 2018

Record last verified: 2018-09

Locations

EG (1)