Propofol Spinal Procedural Sedation for Cesarean Section

NCT ID: NCT03437980

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2018-09-10

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.

Detailed Description

Propofol provides short onset, rapid predictable action, anxiolysis and amnesia and it is more effective than benzodiazepines. Using propofol infusion in low doses during spinal injection in CS did not adversely affect the Apgar scores or the neurological and adaptive fetal outcomes. The general consensus is that procedural sedation is not a routine for spinal interventions, but required for anxious patients. Our hypothesis is that, with the high prevalence of maternal anxiety during cesarean section, ensuring painless comfortable spinal anesthesia may increase the acceptance rate of regional anesthesia during cesarean section.

Conditions

Patient Compliance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

propofol spinal acceptance

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.

Group Type: EXPERIMENTAL

propofol

Intervention Type: 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.

Interventions

propofol

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.

Intervention Type: DRUG

Other Intervention Names

propofol procedural sedation

Eligibility Criteria

Inclusion Criteria

• 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,

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mazy Mazy

associate professor of anesthesia and surgical intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Delta Hospital

Al Mansurah, Dakahlya, Egypt

Mansoura University Hospital

Al Mansurah, Dakahlya, Egypt

Zagazig University Hospital

Zagazig, Sharkya, Egypt

Countries

Egypt

Other Identifiers

R.18.02.23

Identifier Type: -

Identifier Source: org_study_id