## Protocol Section
### Identification Module
**NCT ID:** NCT06426225

**Brief Title:** Spinal Or General Anesthesia For Umblical Hernia Surgery

**Official Title:** Should General Anesthesia or Spinal Aneshtesia With Ketofol Sedation Be Applied in Umblical Hernia Operations ?

#### Organization Study ID Info
**ID:** 1646
#### Organization
**Class:** OTHER
**Full Name:** Ankara City Hospital Bilkent
### Status Module
#### Completion Date
**Date:** 2024-08-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ankara City Hospital Bilkent

#### Responsible Party

**Investigator Affiliation:** Ankara City Hospital Bilkent

**Investigator Full Name:** Nargiz Mammadova

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** In this study, the investigators compared spinal anesthesia under ketofol (ketamine-propofol combination) sedation with general anesthesia in terms of intraoperative and postoperative hemodynamics, respiratory parameters and cost in patients undergoing umbilical hernia operation. the investigator aimed to provide the most appropriate and hemodynamically stable option for the patient, to decrease the complication rates and to reduce the associated costs.

**Detailed Description:** This study was carried out at the Ministry of Health Ankara City Hospital Operating Room, after receiving ethics committee approval.Preoperative evaluation was performed before the operation in cases undergoing elective umbilical hernia surgery.Complications and side effects are explained in detail.Verbal and written consents were obtained from the subjects who agreed to participate in the study.In patients undergoing umbilical hernia surgery, general anesthesia and spinal anesthesia under propofol and ketamine (ketamine-propofol combination) sedation were compared in terms of intraoperative and postoperative hemodynamics, aldrete score, pain score, respiratory parameters, and cost. The patients, who had fasted for 8 hours before the operation, were taken to the operating room without premedication.

In all cases, a peripheral venous catheter cannulated on the dorsal part of the hand (20G, Plusflon i.v. Cannula, India) .Standard monitoring was applied.

Group1. As premedication 0.03mg/kg midazolam was administered . For spinal anesthesia, 15 mg heavy-bupivacaine, sedation was provided with ketofol.

ketamine:propofol mixture was prepared as 1:1 5mg/ml propofol and 5mg/ml ketamine

1 mg/kg ketofol administered i.v. Group2 . As premedication 0.03mg/kg midazolam was administered.In general anesthesia to all patients after induction 3 mg/kg propofol, 0.6 mg/kg rocuronium and 1 mcg/kg fentanyl Bispectral index and non-invasive blood pressure was monitored, a urinary catheter was placed. Anesthesia was maintained with sevoflurane and fentanyl to keep BIS values between 40-60.

### Conditions Module

**Conditions:**

- Umbilical Hernia

- Spinal Aneshtesia

- General Anesthesia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** As premedication 0.03mg/kg midazolam was administered. During general anesthesia, 3 mg/kg propofol, 0.6 mg/kg rocuronium and 1 mcg/kg fentanyl were administered to all patients for induction.

**Intervention Names:**

- Other: General Anesthesia

**Label:** General Anesthesia

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** As premedication 0.03mg/kg midazolam was administered. After premedication Spinal Anesthesia applied. Group will be sedated with ketofol after spinal anesthesia. Ketamine:propofol mixture will be prepared as 1:1 5mg/ml propofol and 5mg/ml ketamine. Surgery will begin when the Ramsey sedation scale reaches 3.

**Intervention Names:**

- Other: Spinal Aneshtesia

**Label:** Spinal Anesthesia

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- General Anesthesia

**Description:** General Anesthesia Applied Group 2 Patients.

**Name:** General Anesthesia

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Spinal Anesthesia

**Description:** Spinal Anesthesia and Ketofol Sedation Applied Group 1 Patients.

**Name:** Spinal Aneshtesia

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** During Perioperative Period Heart rate was measured

**Measure:** Heart Rate

**Time Frame:** preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute

**Description:** non invasive blood pressure measurement

**Measure:** systolic blood pressure

**Time Frame:** preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute

**Description:** non invasive blood pressure measurement

**Measure:** diastolic blood pressure

**Time Frame:** preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute

**Description:** non invasive blood pressure measurement

**Measure:** mean arterial blood pressure

**Time Frame:** preoperative 0. minute, intraoperative 10.minute, intraoperative 20.minute, intraoperative 30.minute, Postoperative 0.minute, Postoperative 10.minute, Postoperative 20.minute, Postoperative 30.minute

**Description:** Length of hospital stay was recorded.

**Measure:** hospital stay

**Time Frame:** From hospital admission to discharge

**Description:** Bill amount during hospitalization

**Measure:** Cost

**Time Frame:** From hospital admission to discharge

#### Secondary Outcomes

**Description:** postoperative numeric rating scale was evaluated, 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable

**Measure:** Postoperative NRS

**Time Frame:** Postoperative 30.minute, Postoperative 12. hour

**Description:** Postoperative Aldrete score was evaluated.

**Measure:** Postoperative Aldrete Score

**Time Frame:** Postoperative first 1 hour

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ASA I-II patients between the ages of 18 and 65 who would undergo Umbilical hernia surgery were included in the study.

Exclusion Criteria:

* who do not accept the procedure
* serious cardiovasculer disease ,renal, hematological (bleeding diathesis, under anticoagulant therapy, those with hemoglobin value below 10 g/dl) disease, hepatic disease, cerebrovascular, neurological or psychiatric diseases,
* those who are contraindicated for spinal anesthesia,
* Those who are allergic to one of the local anesthetics to be used, with drug and alcohol addiction,
* pregnant or breastfeeding
* using drugs and analgesics effective on the central nervous system were excluded from the study.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nargiz188855@gmail.com

**Name:** Nargiz Mammadova

**Phone:** +905356570987

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** KROBOT, R. i PREMUŽIĆ, J. (2013). Comparison of general and spinal anaesthesia in patients undergoing open ventral hernia repair. Periodicum biologorum, 115 (2), 225-229. Preuzeto s https://hrcak.srce.hr/105984

**Citation:** Germano P, Siboni S, Milito P, Mautone G, Resta M, Bonavina L. Ventral hernia repair under neuraxial anesthesia. Eur Surg. 2022;54(1):54-58. doi: 10.1007/s10353-021-00731-x. Epub 2021 Jul 20.

**PMID:** 34306042

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000007232

- Term: Infant, Newborn, Diseases

- ID: D000006555

- Term: Hernia, Ventral

- ID: D000046449

- Term: Hernia, Abdominal

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

### Condition Browse Module - Browse Leaves

- ID: M9625

- Name: Hernia

- Relevance: HIGH

- As Found: Hernia

- ID: M9632

- Name: Hernia, Umbilical

- Relevance: HIGH

- As Found: Umbilical Hernia

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M10276

- Name: Infant, Newborn, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9633

- Name: Hernia, Ventral

- Relevance: LOW

- As Found: Unknown

- ID: M25675

- Name: Hernia, Abdominal

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006554

- Term: Hernia, Umbilical

- ID: D000006547

- Term: Hernia

### Intervention Browse Module - Ancestors

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PsychDr

- Name: Psychotropic Drugs

### Intervention Browse Module - Browse Leaves

- ID: M8418

- Name: Fentanyl

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: HIGH

- As Found: Imaging

- ID: M1666

- Name: Rocuronium

- Relevance: LOW

- As Found: Unknown

- ID: M11845

- Name: Midazolam

- Relevance: LOW

- As Found: Unknown

- ID: M10674

- Name: Ketamine

- Relevance: LOW

- As Found: Unknown

- ID: M18307

- Name: Propofol

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000777

- Term: Anesthetics

### Misc Info Module

- Version Holder: 2024-05-31
