Does Intralipid Infusion Can Reverse the Spinal Anesthesia Effect in Day Case Surgery?

NCT ID: NCT07025343

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-08-31

Brief Summary

This study aims to evaluate the effect of intralipid infusion on reversing the spinal anesthesia effect in day case surgery.

Detailed Description

The increasing demand for day-case surgery has led to a growing interest in developing strategies to provide patients with a more convenient, cost-effective, and less invasive alternative to traditional inpatient procedures.

Spinal anesthesia, in particular, is a widely used technique in day-case surgery due to its ability to provide excellent analgesia with minimal side effects.

Intravenous lipid emulsion therapy is commonly used to treat local anesthetic systemic toxicity (LAST) and has demonstrated some efficacy in treating other drug toxicities, particularly cardiotoxicity from lipophilic drugs.

Conditions

Intralipid Infusion; Spinal Anesthesia; Day Case Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group S

Patients (\>70kg will receive 100 ml, \<70 will receive 1.5ml/kg) of 20% intravenous lipid emulsion at the end of surgery as a study group.

Group Type: EXPERIMENTAL

Lipid emulsion

Intervention Type: OTHER

Patients (\>70kg will receive 100 ml, \<70 will receive 1.5ml/kg) of 20% intravenous lipid emulsion at the end of surgery as a study group.

Group C

Patients will not receive intravenous lipid emulsion as a control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lipid emulsion

Patients (\>70kg will receive 100 ml, \<70 will receive 1.5ml/kg) of 20% intravenous lipid emulsion at the end of surgery as a study group.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age from 18 to 65 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-II.
• Scheduled for day-case surgery under spinal anesthesia.
• Time of surgery less than 90 min.

Exclusion Criteria

• Patients with contraindications for outpatient surgery or spinal anesthesia.
• Local anaesthetic (LA) allergy.
• Those receiving anticoagulant therapy.
• Emergency cases.
• Pregnant cases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Sharara, MD

Lecturer of Anesthesiology, Intensive Care and Pain Medicine, Faculty of Medicine, Benha University, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Banha University

Banhā, Banha, Egypt

Countries

Egypt

Other Identifiers

RC 6-1-2025

Identifier Type: -

Identifier Source: org_study_id