## Protocol Section
### Identification Module
**NCT ID:** NCT06165679

**Brief Title:** Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients

**Official Title:** Comparison Between the Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients Undergoing Endoscopic Urological Surgeries: A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** N-439-2023
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2024-07-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-12

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-11

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-20

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2023-12-11
**Type:** ACTUAL
**Study First Submit Date:** 2023-12-02
**Study First Submit QC Date:** 2023-12-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** AbdElKhalik Mahmoud Shaban

**Investigator Title:** Lecturer of anaesthesia

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Data comparing prilocaine vs bupivacaine in equipotent doses in the elderly are lacking; therefore, the study will compare the effect of prilocaine vs bupivacaine on hemodynamics in spinal anesthesia for geriatric patients undergoing endoscopic urological surgeries

### Conditions Module

**Conditions:**

- Hemodynamic Instability

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 112

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Prilocaine

**Label:** Prilocaine group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: Bupivacaine

**Label:** Bupivacaine GROUP

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Prilocaine group

**Description:** The patients will receive a single injection of spinal anesthesia using prilocaine plus fentanyl

**Name:** Prilocaine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Bupivacaine GROUP

**Description:** The patients will receive a single injection of spinal anesthesia using Bupivacaine plus fentanyl

**Name:** Bupivacaine

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** Mean and systolic arterial blood pressure values after spinal anesthesia

**Measure:** Mean and systolic arterial blood pressure values

**Time Frame:** Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia

**Description:** Heart rate after spinal anesthesia

**Measure:** Heart rate

**Time Frame:** Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia

#### Primary Outcomes

**Description:** Incidence of hypotension from local anesthetic injection

**Measure:** Hypotension

**Time Frame:** Till 30 minutes after spinal anesthesia.

#### Secondary Outcomes

**Description:** Total doses of vasopressor drugs used for hypotension treatment

**Measure:** Use of vasopressor drugs

**Time Frame:** Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients aged 65 years old and above.
* Both genders.
* Patients scheduled to undergo endoscopic urological surgeries.
* ASA I and II class.

Exclusion Criteria:

* Patient refusal.
* Known local anesthetic (LA) allergy.
* Bleeding disorders.
* Skin lesions or infections at site of needle insertion.
* Hypertensive patients.
* Patients candidate for transurethral resection of the prostate
* ASA III and VI class

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Contacts:**

***Contact 1:***

- **Email:** dr.abdo86@gmail.com

- **Name:** abdelkhalek m Samy

- **Phone:** 01025854248

- **Role:** CONTACT

***Contact 2:***

- **Name:** Maged A AbdelAziz

- **Role:** SUB_INVESTIGATOR

***Contact 3:***

- **Name:** Mohamed R Ahmed

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Mohamed A Morsy

- **Role:** SUB_INVESTIGATOR

**Country:** Egypt

**Facility:** Kasr Alaini hospital

**Status:** RECRUITING

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M5315

- Name: Bupivacaine

- Relevance: HIGH

- As Found: Following

- ID: M8418

- Name: Fentanyl

- Relevance: LOW

- As Found: Unknown

- ID: M14191

- Name: Prilocaine

- Relevance: HIGH

- As Found: Weighted

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002045

- Term: Bupivacaine

- ID: D000011318

- Term: Prilocaine

### Misc Info Module

- Version Holder: 2024-05-24
