## Protocol Section
### Identification Module
**NCT ID:** NCT03925779

**Brief Title:** Conscious Sedation for Outpatient Colonoscopy

**Official Title:** Dexmedetomidine Versus Propofol-Remifentanil Conscious Sedation for Outpatient Colonoscopy: A Prospective Randomized Double-blind Trial.

#### Organization Study ID Info
**ID:** 2019/3/15/9
#### Organization
**Class:** OTHER
**Full Name:** Menoufia University
### Status Module
#### Completion Date
**Date:** 2021-01-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-01-08

**Type:** ACTUAL

**Last Update Submit Date:** 2021-01-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2019-06-15

**Type:** ACTUAL

**Status Verified Date:** 2021-01

#### Study First Post Date
**Date:** 2019-04-24
**Type:** ACTUAL
**Study First Submit Date:** 2019-04-21
**Study First Submit QC Date:** 2019-04-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Menoufia University

#### Responsible Party

**Investigator Affiliation:** Menoufia University

**Investigator Full Name:** Abd-Elazeem Abd-Elhameed Elbakry

**Investigator Title:** Associate professor of anaesthesia

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Although colonoscopy is a mildly painful procedure, the pain and the procedure itself are distressful for most patients. This raises the attention for using different sedation regimens aiming at maintaining optimal sedation level with maintained airway and stable haemodynamics all through the procedure. The present study was scheduled to investigate the sedative efficacy of dexmedetomedine versus propofol-remifentanil for outpatient colonoscopy.

**Detailed Description:** Eighty patients undergoing outpatient colonoscopy will be randomized into two equal groups. In Dexmedetomidine (DEX) group the patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure. In the PR group, propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. If the patient complained of pain or discomfort, the infusion rates of dexmedetomidine (DEX group) or propofol-remifentanil (P-R group) will be increased. If the higher limit of the dose range of the study drugs reached, additional fentanyl 0.5 μg/kg i.v. boluses will be administered. Rescue medication consisting of propofol boluses of 0.5 mg/kg i.v. will be given if the previous protocol failed. Sedation score,haemodynamics, end-tidal carbon dioxide, oxygen saturation, total fentanyl, propofol bolus doses, patient and colonoscopist satisfaction and side effects will be recorded.

### Conditions Module

**Conditions:**

- Conscious Sedation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** A blinded investigator that was not involved in the anaesthetic management of the patients, collected the intra-operative and postoperative data. The patients and colonoscopist were blinded to group allocation. For blinding purposes, two drug infusion pumps were used in every patient where the infusion pumps and i.v. connection lines were concealed to avoid identification.

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 80

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure

**Intervention Names:**

- Drug: Dexmedetomidine

**Label:** (Dexmedetomidine)Dex group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min.

**Intervention Names:**

- Drug: Propofol

- Drug: Remifentanil

**Label:** Propofol-Remifentanil (P-R) group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- (Dexmedetomidine)Dex group

**Description:** dexmedetomidine sedation

**Name:** Dexmedetomidine

**Other Names:**

- dexmedetomidine infusion

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Propofol-Remifentanil (P-R) group

**Description:** propofol sedation

**Name:** Propofol

**Other Names:**

- propofol infusion

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Propofol-Remifentanil (P-R) group

**Description:** Remifentanil sedation

**Name:** Remifentanil

**Other Names:**

- Remifentanil infusion

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Degree of sedation by Ramsay sedation score from 1 inadequate sedation to 6 excessive sedation.

**Measure:** Sedation

**Time Frame:** Perioperative

#### Secondary Outcomes

**Description:** Mean arterial blood pressure in mmHg

**Measure:** Mean arterial blood pressure

**Time Frame:** Perioperative

**Description:** Heart rate in beats/minutes

**Measure:** Heart rate

**Time Frame:** Perioperative

**Description:** Arterial oxygen saturation as a percentage of the total haemoglobin.

**Measure:** Oxygen saturation

**Time Frame:** Perioperative

**Description:** Number of patients with hypotension

**Measure:** Hypotension

**Time Frame:** Perioperative

**Description:** Number of patients with bradycardia

**Measure:** Bradycardia

**Time Frame:** Perioperative

**Description:** Measured by visual analogue scale \[from 0 "no pain" to 10 "worst imaginable pain"\]

**Measure:** Analgesia

**Time Frame:** Perioperative

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ASA I or II physical status
* 18-65 years
* Scheduled for elective colonoscopy

Exclusion Criteria:

* History of allergy to any of the study drugs
* Alcohol or drug abuse.
* Second and third-degree heart block.
* Morbid obesity.
* Pregnant and lactating women.
* Psychiatric disorders.
* Severe cardiac, respiratory, renal, and liver diseases

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Faculty of Medicine

**State:** Shebin El-kom

**Zip:** 32511

#### Overall Officials

**Official 1:**

**Affiliation:** Associate professor

**Name:** Abd-Elazeem A Elbakry, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000058647

- Term: Adrenergic alpha-2 Receptor Agonists

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018686

- Term: Anesthetics, Intravenous

- ID: D000018681

- Term: Anesthetics, General

- ID: D000000777

- Term: Anesthetics

- ID: D000000701

- Term: Analgesics, Opioid

- ID: D000009294

- Term: Narcotics

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M22662

- Name: Dexmedetomidine

- Relevance: HIGH

- As Found: Twice daily

- ID: M18307

- Name: Propofol

- Relevance: HIGH

- As Found: COVID-19

- ID: M1696

- Name: Remifentanil

- Relevance: HIGH

- As Found: SARS-

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M20766

- Name: Anesthetics, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M20761

- Name: Anesthetics, General

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M12245

- Name: Narcotics

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000020927

- Term: Dexmedetomidine

- ID: D000077208

- Term: Remifentanil

- ID: D000015742

- Term: Propofol

### Misc Info Module

- Version Holder: 2024-05-24
