Propofol Spinal Procedural Sedation for Cesarean Section

NCT03437980 | Completed

• 1 other identifier: R.18.02.23
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 3

Brief Summary

Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians. According to evidence, guidelines and quality markers, regional anesthesia is preferred over general anesthesia in obstetric surgery. A high level of anxiety is present in obstetric patients preoperatively. Patients with high anxiety tend to prefer general anesthesia for cesarean section. The anxiety can be reduced variably by non-pharmacologic and pharmacologic methods. The evidence supports the benefits of procedural sedation for distressed, anxious pregnant women.

Conditions

Patient Compliance

Outcome Measures

Primary Outcomes (1)

• The rate of acceptance of spinal anesthesia if propofol sedation is added during the procedure.

  percent

  30 minutes preoperative.

Secondary Outcomes (2)

• The rate of initial acceptance of spinal anesthesia without sedation.

  30 minutes preoperative.

• The anxiety score.

  30 minutes preoperative,10 minutes after spinal injection, and 30 minutes after stay at recovery room.

Other Outcomes (8)

• The patient satisfaction regards the spinal anesthesia decision.

  30 minutes at recovery room.

• The total utilized dose of propofol.

  1 minute after completion of spinal procedure, and 5 minutes at the end of cesarean section.

• The rate of premature termination of spinal procedure (failure rate).

  20 minutes preoperative.

Study Arms (1)

propofol spinal acceptance

EXPERIMENTAL

The surgeon and the anesthetist will discuss the exclusion criteria. Then they will discuss the information's about spinal and general anesthesia with the illegible patients, also reply the patient's questions in a preoperative visit. The primary decision for the patient; either spinal or general anesthesia will be recorded. The patients refusing spinal anesthesia will be discussed again to detect the rate of acceptance of spinal anesthesia if propofol sedation is ensured during the procedure to provide a painless spinal injection. The final decision will be applied; either spinal with procedural sedation, or general anesthesia.

Drug: propofol

Interventions

propofol DRUG

A bolus of 0.7 mg/kg will be given initially, additional incremental doses of 20 mg propofol will be given if the patient complained of pain or moved arms towards the back. Patients will be sitting on the middle of the operating table facing towards the table's foot. The table's foot will be dropped 45 degrees for a comfortable chair position, Monitoring through pulse oximeter (SaO2), non-invasive blood pressure (NIBP) adjusted every 2 minutes automatic measuring and capnography tube in contact with nostrils.

Also known as: propofol procedural sedation

propofol spinal acceptance

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: patients scheduled for an elective cesarean section.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for elective cesarean section,
• Age: 18 - 40 years,
• American Society of Anesthesiologists I - III,
• Patients may present any of the following conditions:
• Respiratory diseases as bronchial asthma
• Hepatic compromise,
• Preeclampsia,
• Anemia with hemoglobin 10 g/dl,
• Previous sections,
• Obese with BMI more than 35%,
• Any criteria of difficult intubation, Compromised fetus as premature delivery, History of complications or non-satisfaction after general anesthesia during previous cesarean section,

You may not qualify if:

• Patients refusing to participate in the study,
• Known psychiatric disease,
• Addiction medications,
• Communication barrier,
• Absolute or relative contraindication for spinal anesthesia,
• Bad obstetric history, complicated pregnancy, congenital fetal anomaly.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (3)

Delta Hospital

Al Mansurah, Dakahlya, 35516, Egypt

Location

Mansoura University Hospital

Al Mansurah, Dakahlya, 35516, Egypt

Location

Zagazig University Hospital

Zagazig, Sharkya, 44519, Egypt

Location

MeSH Terms

Conditions

Patient Compliance

Interventions

Propofol

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: February 4, 2018
• First Posted: February 19, 2018
• Study Start: April 1, 2018
• Primary Completion: July 10, 2018
• Study Completion: September 10, 2018
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

EG (3)