Effects of Anaesthesia on Inflammatory Markers

Assiut University

Status: Completed

Conditions: Inflammatory Response

Treatments: Drug: morphine+lidocaine; Drug: Saline; Drug: Morphine Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT04630938

17300478

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 3 patient groups, including a placebo group

G-M

Active Comparator group

Description:

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

Treatment:

Drug: Morphine Sulfate

G-ML

Active Comparator group

Description:

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.

Treatment:

Drug: morphine+lidocaine

G-0

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline