Effects of Anaesthesia on Inflammatory Markers

NCT04630938 | Completed DMC

• 1 other identifier: 17300478
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Response

Outcome Measures

Primary Outcomes (1)

• Visual analogue score

  a scale to measure pain intensity graded from 0 = no pain to 10 = worst pain

  24 hours

Study Arms (3)

G-M

ACTIVE COMPARATOR

Received classic general Anesthesia, intrathecal (Bupivacaine 15 mg, morphine 4 microgram/kg) plus saline infusion intraoperative and postoperative.

Drug: Morphine Sulfate

G-ML

ACTIVE COMPARATOR

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.

Drug: morphine+lidocaine

G-0

PLACEBO COMPARATOR

Received General Anesthesia and Spinal anesthesia as previously described with saline infusion in the same design as in the previous two groups.

Drug: Saline

Interventions

Morphine Sulfate DRUG

intrathecal morphine will be added to anaesthetics

G-M

morphine+lidocaine DRUG

local anesthetic will be infused intravenously

G-ML

Saline DRUG

intravenous saline infusion

G-0

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Esam A. Hamed

Asyut, 71515, Egypt

Location

MeSH Terms

Interventions

Morphine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: November 16, 2020
• Study Start: October 24, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 30, 2021
• Last Updated: February 24, 2022

Record last verified: 2022-02

Locations

EG (1)