Prevention of Shivering Associated With Spinal Anesthesia | NCT06082076

Studies
Prevention of Shivering Associated With Spinal Anesthesia

NCT06082076

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Oct 13, 2023Actual

Enrollment

90Estimated

Phase

Phase 2Phase 3

Conditions

Shivering, Spinal Anesthesia

Interventions

Dexmedetomidine
Ketamine
Meperidine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2023Estimated

Primary Completion Date

Nov 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Oct 8, 2023

First Submission Date that Met QC Criteria

Oct 8, 2023

First Posted Date

Oct 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2023

Last Update Posted Date

Oct 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to compare the effectiveness of prophylactic use of intravenous (IV) dexmedetomidine VS ketamine and meperidine(as a control group) in prevention of shivering associated with intrathecal anesthesia in patients undergoing knee arthroscopy

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Group D (dexmedetomidine group)	Active Comparator	Drug: Dexmedetomidine
Group K (ketamine group)	Active Comparator	Drug: Ketamine
Group C (control group)	Placebo Comparator	Drug: Meperidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	Patients will receive dexmedetomidine 0.5 mcg/kg diluted in 10 mL of NS given as IV infusion over 10 min before induction of spinal anesthesia	Group D (dexmedetomidine group)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of shivering	Incidence of shivering post intrathecal anesthesia is recorded	During operation time

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- BMI 20-30 Scheduled patients for knee arthroscopy under spinal anesthesia. American Society of Anesthesiologists (ASA) physical status: I and II

Exclusion Criteria:

Patient refusal Aged less than 18 years or lesser than 150 cm in height Pregnant woman Allergy to the studied drugs. Patients with contraindications to spinal anesthesia. Patients with advanced decompensated cardiac, respiratory,renal or hepatic diseases, ASA III-IV Coagulopathy or thrombocytopenia CNS diseases as epilepsy, stroke or psychiatric illness.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Ga Mohammed, Resident	Contact	+201091339220		ahmedgalalm678@gmail.com

Overall Officials

Name	Affiliation	Role
Essam Ez Abdelhakeem, Professor	Assiut University	Study Director
Seham Mo Moeen, Professor	Assiut University	Study Director

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D007649	Ketamine
D008614	Meperidine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided