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

NCT07025343 | Completed

• 1 other identifier: RC 6-1-2025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intralipid Infusion; Spinal Anesthesia; Day Case Surgery

Outcome Measures

Primary Outcomes (1)

• Onset time of the motor block

  The onset time of the motor block using the modified Bromage scale will be assessed. The motor block will be measured when the maximum dermatomal spread is achieved using the modified Bromage scale (0: no motor block, 1: hip blocked, 2: hip and knee blocked, and 3: hip, knee, and ankle blocked).

  Intraoperatively

Secondary Outcomes (7)

• Duration of motor block

  Intraoperatively

• Time till home readiness

  24 hours postoperatively

• Time to the 1st rescue analgesia

  24 hours postoperatively

• Total tramadol consumption

  24 hours postoperatively

• Degree of pain

  24 hours postoperatively

Study Arms (2)

Group S

EXPERIMENTAL

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.

Other: Lipid emulsion

Group C

NO INTERVENTION

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

Interventions

Lipid emulsion 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 S

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 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.

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Banha University

Banhā, Banha, 13511, Egypt

Location

MeSH Terms

Interventions

Fat Emulsions, Intravenous

Intervention Hierarchy (Ancestors)

Emulsions; Colloids; Dosage Forms; Pharmaceutical Preparations; Parenteral Nutrition Solutions; Pharmaceutical Solutions; Solutions; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Intensive Care and Pain Medicine, Faculty of Medicine, Benha University, Egypt.

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 17, 2025
• Study Start: February 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)