Effect of Intraoperative Magnesium Sulphate on the Occurrence of Postoperative Delirium

NCT05632159 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-11-30

No results posted yet for this study

Summary

Anaesthesia-related complications and mortality have been significantly reduced in the last years.(1) Nevertheless, anaesthesia-related side effects, such as post-operative delirium and sleep disturbances should not be underestimated. These side effects are economically challenging because they may lead to prolonged hospital stay and change in lifestyle condition. (2) After general anesthesia' sleep disturbances frequently occur. They are featured by insomnia' hyperinsomnia' narcolepsy' and changed sleep structure. (3.4) There are a lot of risk factors associated with post-operative sleep disturbance such as patient age, preoperative comorbidity, severity of surgical trauma, postoperative pain, postoperative complications and presence of pre-operative fatigue and depression. (5) Insomnia is one of the most prevalent health problems during pre-operative period and after post-operative recovery. It can lead to increase incidence of post-operative complications such as delayed recovery , anxiety and delirium (6).

Post-operative delirium is also one of the most common complications following anaesthesia with frequency estimates ranging from 10 to 50%. It is defined as delirium occurring 24 to 72 hours after surgery. (7) There are multiple risk factors for developing postoperative delirium including pre-existing dementia, old age, medical co-morbidities, and psycopathological symptoms. The recognition and treatment of Post-operative delirium is critically important because postoperative delirium is associated with poor outcomes including functional decline, dementia, cognitive impairment, increased hospital length of stay , increased mortality ( 11% increasing in the risk of death at 3 months and up to a 17% increased risk of death at 1 year. (8)

Animal studies have found that Magnesium can regulate melatonin production which is a hormone that guide body sleep wake cycle (9) . Magnesium is an essential cofactor for many enzymatic reactions' especially those that are involved in energy metabolism and neurotransmitter synthesis. It is a cofactor involved in more than 300 enzyme systems' regulates diverse biochemical reactions in the body (10.11) .

Magnesium supplements were used to improve insomnia symptom among older people in a double blinded placebo controlled clinical trial(12). Low dietary Magnesium intake was found to be significantly associated with depression which is a potential risk factor for insomnia(13). Also using Magnesium sulphate as an adjuvant has been associated with significantly less analgesic requirements and reducing postoperative pain which can improve quality of sleep and decrease insomnia symptoms.(14)

AIM OF THE STUDY The aim of this work is to identify the potential predictors of postoperative delirium and insomnia in patients undergoing lumbar fixation under general anesthesia, and to evaluate the effect of intraoperative administration of Magnesium sulphate on the occurrence of post-operative delirium and insomnia in those patients.

Conditions

  • Patients Undergoing Lumbar Fixation

Interventions

DRUG

Mg sulphate

Induction of anesthesia will be done by injecting fentanyl 2 μg/kg, propofol1.5-2.5 mg/kg and atracurium 0.5 mg/kg for muscle relaxation. With extra administration of intraoperative Magnesium sulphate 30 mg /kg as loading dose over 10 min then 10 mg /kg/ has maintenance dose

DRUG

conventional anaesthesia

Induction of anesthesia will be done by injecting fentanyl 2 μg/kg, propofol1.5-2.5 mg/kg and atracurium 0.5 mg/kg for muscle relaxation.

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-02-01
Completion
2023-03-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05632159 on ClinicalTrials.gov