Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015857
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
ahmed elsakka, Kasr El Aini Hospital

Brief Summary:
Hypotension following spinal anesthesia for cesarean section is a serious problem. In this study we investigated the effect of the vasopressors phenylephrine and noradrenaline on postspinal hypotension.

Condition or disease Intervention/treatment Phase
Adverse Anesthesia Outcome Drug: phenylephrine Drug: Norepinephrine Drug: Bupivacaine Drug: Fentanyl Drug: Placebo (normal saline) Phase 2

Detailed Description:

On arrival to the operating room, an 18g cannula will be inserted and monitors will be applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor). Patients will receive spinal anesthesia with 500 ml rapid crystalloid co-load. Ten milligrams heavy bupivacaine in addition to 20 mcg fentanyl will be injected in L3-L4 or L4-L5 interspace using 25 g spinal needle in the sitting position.

After spinal block, patients will be randomly allocated into one of two groups:

  • Phenylephrine group (n=100)
  • Norepinephrine group (n=100)

Patients who shows SBP above 140 mmHg or heart rate below 55 bpm after the first vasopressor dose will not receive the infusion. The infusion will stop if the SBP was above 140 mmHg or if the heart rate was below 55 bpm. Patients will be positioned in the supine position with left lateral tilt. Block success will be assessed using pinprick, patients with failed block will be excluded from the study. The highest sensory block level will be assessed after 5 minutes from intrathecal injection. Co-hydration will be continued till maximum of 1.5 litres.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Comparison Between Phenylephrine and Norepinephrine Boluses in Prevention of Post-spinal Hypotension During Cesarean Delivery
Actual Study Start Date : January 2017
Actual Primary Completion Date : March 2017
Actual Study Completion Date : April 2017


Arm Intervention/treatment
Active Comparator: phenylephrine,
- Phenylephrine group (n=100): will receive 100 mcg phenylephrine as a single bolus just after intrathecal injection of 10 mg bupivacaine plus 20 mcg fentanyl. The dose will be diluted in 5 mL and given over seconds. A continuous infusion with placebo (normal saline) will start after the first bolus.
Drug: phenylephrine
- phenylephrine; a vasopressor drug given to prevent post spinal hypotension

Drug: Bupivacaine
intrathecal bupivacaine 10 mg will be given in both groups

Drug: Fentanyl
intrathecal fentanyl 20 mcg will be given in both groups

Drug: Placebo (normal saline)
Active Comparator: norepinephrine
- Norepinephrine group (n=100): will receive bolus of norepinephrine (10 mcg) directly after spinal block using 10 mg bupivacaine plus 20 mcg fentantanyl followed by continuous infusion of norepinephrine with a rate of 0.1 mcg/kg/min till delivery of the fetus.
Drug: Norepinephrine
- norepinephrine; a vasopressor drug given to prevent post spinal hypotension

Drug: Bupivacaine
intrathecal bupivacaine 10 mg will be given in both groups

Drug: Fentanyl
intrathecal fentanyl 20 mcg will be given in both groups




Primary Outcome Measures :
  1. Incidence of post spinal hypotension (PSH) defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus) [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. systolic and diastolic blood pressures measured in mm Hg [ Time Frame: 2 hours ]
  2. heart rate measured in beats per minute [ Time Frame: 2 hours ]
  3. nausea and vomiting measured in number of attacks [ Time Frame: 2 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • full term singleton parturients
  • elective cesarean sections

Exclusion Criteria:

  • cardiac morbidities
  • hypertensive disorders of pregnancy
  • peripartum bleeding
  • body mass index > 35 will be excluded from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015857


Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
Layout table for investigator information
Study Chair: Shereen Refaat, M.D. Lecturer of anesthesia Faculty of medicine Cairo university
Study Chair: Tamer M Rook, M.D. Lecturer of anesthesia Faculty of medicine Cairo university
Layout table for additonal information
Responsible Party: ahmed elsakka, Principal investigator and lecturer of anesthesia, faculty of medicine cairo university, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03015857    
Other Study ID Numbers: cesarean sections
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypotension
Vascular Diseases
Cardiovascular Diseases
Phenylephrine
Oxymetazoline
Norepinephrine
Fentanyl
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Cardiotonic Agents
Mydriatics
Autonomic Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists