Effects of Anaesthesia on Inflammatory Markers

NCT ID: NCT04630938

Last Updated: 2022-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-24

Study Completion Date

2021-10-30

Brief Summary

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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

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Conditions

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Inflammatory Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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G-M

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

Group Type ACTIVE_COMPARATOR

Morphine Sulfate

Intervention Type DRUG

intrathecal morphine will be added to anaesthetics

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.

Group Type ACTIVE_COMPARATOR

morphine+lidocaine

Intervention Type DRUG

local anesthetic will be infused intravenously

G-0

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

intravenous saline infusion

Interventions

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Morphine Sulfate

intrathecal morphine will be added to anaesthetics

Intervention Type DRUG

morphine+lidocaine

local anesthetic will be infused intravenously

Intervention Type DRUG

Saline

intravenous saline infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Esam Hamed

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Esam A. Hamed

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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17300478

Identifier Type: -

Identifier Source: org_study_id

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