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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05596669
Other study ID # Nirvana Ahmed 02
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 1, 2021
Est. completion date May 15, 2022

Study information

Verified date October 2022
Source Egymedicalpedia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ketamine and magnesium-ketamine are two analgesics that are being studied for use as adjuvants. They were shown to have anaesthetic and analgesic properties, and as a consequence of this finding, it has been postulated that they may have a role in minimising the requirement for analgesic drugs during the postoperative period. The major objective of the research was to examine the pain-relieving effects of ketamine vs ketamine magnesium infusion, as well as their influence on postoperative morphine consumption following nephrectomy; the secondary goal is to assess hemodynamic effects and pain severity.


Description:

Renal necrosis factor (RN) therapy, which includes ipsilateral adrenalectomy, was first utilized to treat renal cortical tumours in 1969. A radical nephrectomy is a surgical surgery in which the whole kidney, as well as the surrounding fat and, in some cases, the adrenal gland and lymph nodes, are removed. This operation is carried out as an inpatient . Opioid use, on the other hand, can result in considerable side effects and adverse events, which can result in much longer hospital stays and higher postsurgical hospital costs. Although opioid-based analgesia is essential for postoperative pain management, opioid usage may have serious adverse effects . Finding techniques to limit opioid intake in the postoperative period is essential because cases that got increased opioid dosages are more likely to have the negative effects. Using non-opioid analgesics alongside opioid analgesics, known as analgesia of multi-modes, to enhance post-operative pain management while reducing the usage of the opioids. . Ketamine, also and magnesium-ketamine are two analgesics wich are non-opioid that are being studied for use like opioid analgesic adjuvants. They were discovered to have anaesthetic and analgesic properties, and it has been proposed that as a result of this discovery, they may have a great contribution in reducing the need for postoperative analgesic medications .


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 15, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group 35 Years to 50 Years
Eligibility Inclusion Criteria: - Patients with elective nephrectomy Exclusion Criteria: - Pregnant women - Cases with severe chronic disease as liver cell failures, CHF - cases with allergies to ketamine and magnesium sulphate - cases with a history of current regular use of (analgesic, anticonvulsant, antidepressant) - chronic pain. - mental illness.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ketamine
to examine the pain-relieving effects of ketamine vs ketamine magnesium infusion, as well as their influence on postoperative morphine consumption following nephrectomy; the secondary goal is to assess hemodynamic effects and pain severity

Locations

Country Name City State
Egypt October 6 University Hospital Giza

Sponsors (1)

Lead Sponsor Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of Post-operative Pain Assessment of the pain post-operatively in patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain,The Ramsay sedation scale was utilized to gauge postoperative sedation levels. 24-hour analgesic after nephrectomy
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