Effects of Anaesthesia on Inflammatory Markers

February 14, 2022 updated by: Esam Hamed, Assiut University

Effects of Anesthetics on Inflammatory Markers in Patients Undergoing Abdominal Surgeries.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Esam A. Hamed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: G-M
Received classic general Anesthesia, intrathecal (Bupivacaine 15 mg, morphine 4 microgram/kg) plus saline infusion intraoperative and postoperative.
Drug: Morphine Sulfate
intrathecal morphine will be added to anaesthetics
ACTIVE_COMPARATOR: G-ML
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
local anesthetic will be infused intravenously
PLACEBO_COMPARATOR: G-0
Received General Anesthesia and Spinal anesthesia as previously described with saline infusion in the same design as in the previous two groups.
Drug: Saline
intravenous saline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue score
Time Frame: 24 hours
a scale to measure pain intensity graded from 0 = no pain to 10 = worst pain
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 24, 2020

Primary Completion (ACTUAL)

October 1, 2021

Study Completion (ACTUAL)

October 30, 2021

Study Registration Dates

First Submitted

July 12, 2020

First Submitted That Met QC Criteria

November 13, 2020

First Posted (ACTUAL)

November 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17300478

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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