Effects of Anaesthesia on Inflammatory Markers

Not Applicable

Completed

• Conditions: Inflammatory Response
• Interventions: Drug: morphine+lidocaine; Drug: Saline; Drug: Morphine Sulfate

• Registration Number: NCT04630938
• Lead Sponsor: Assiut University

Brief Summary

undertake confidently both open and laparoscopic cholecystectomy. Major types of body injuries surgical or accidental; evoke a temporary, yet predictable systemic inflammatory response caused by hormonal, immunological and metabolic mediators. This inflammatory response is essential for tissue repair and has evolved to maximize the organisms' healing potential. In healthy individuals the inflammatory response to major surgery is well balanced consisting of pro- and anti-inflammatory mediators. The severity of injury, the occurrence of surgical complications and its accompanying level of stress may hinder the balance of the inflammatory response6.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-12
• Study Start: 2020-10-24
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-16
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Adult patients aging 18 - 55 years old
• Patients scheduled for abdominal surgeries
• Patients with American Society of Anesthesiologists (ASA) I, II physical status

Exclusion Criteria

• Patients' refusal.
• Critically ill patients.
• Patients who have contraindications to regional anesthesia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G-ML	morphine+lidocaine	Received classic general Anesthesia, intrathecal morphine in a dose of 4 microgram/kg, and intravenous lidocaine in a loading dose of 1.5 mg/kg, then 2 mg/min with the saline infusion over the time of the operation and the next 4 hours postoperative.
G-0	Saline	Received General Anesthesia and Spinal anesthesia as previously described with saline infusion in the same design as in the previous two groups.
G-M	Morphine Sulfate	Received classic general Anesthesia, intrathecal (Bupivacaine 15 mg, morphine 4 microgram/kg) plus saline infusion intraoperative and postoperative.

Primary Outcome Measures

Name	Time	Method
Visual analogue score	24 hours	a scale to measure pain intensity graded from 0 = no pain to 10 = worst pain

Trial Locations

Locations (1)

Esam A. Hamed; 🇪🇬 Assiut, Egypt