NCT05865080

Brief Summary

Hypotension is the most frequent side effect of intrathecal anesthesia, with a found incidence of more than 80%. With a frequency of between 40% and 60% in patients undergoing surgery, Perioperative shivering is a serious consequence that frequently follows neuraxial anesthesia. This study aimed to determine the multiple advantages of intravenous minimal dose ketamine for intrathecal anesthesia in patients undergoing cesarean delivery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

April 18, 2023

Last Update Submit

May 18, 2023

Conditions

Hemodynamic Instability

Keywords

spinal anesthesiaobstetric anesthesia

Outcome Measures

Primary Outcomes (1)

  • Hemodynamics

    Primary outcomes: Hemodynamic parameters (MAP and HR). Secondary outcomes 1. Incidence of intraoperative shivering. 2. The postoperative pain was assessed by VAS score. 3. Sedation score in between groups. 4. Fetus evaluated by Apgar score. 5. Postoperative side effects as nausea, vomiting, nystagmus, diplopia, and hallucinations.

    Up to 24 hours after operation

Study Arms (2)

group K

ACTIVE COMPARATOR

group K (63 patients): Received 0.3 mg/kg of ketamine IV diluted to 10 ml followed by infusion 0.1 mg/kg/hr. as 20 ml solution,

Drug: Ketamine

group C

PLACEBO COMPARATOR

group C (Controlled) (63 patients): Received 10 ml of normal saline followed by infusion of 0.1 ml/kg/hr. as 20 ml solution.

Drug: Placebo

Interventions

KetamineDRUG

0.3 mg/kg of ketamine IV diluted to 10 ml followed by infusion 0.1 mg/kg/hr. as 20 ml solution before spinal anesthesia

group K
PlaceboDRUG

Normal saline

group C

Eligibility Criteria

Age21 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Twins and preterm birth.
  • Hypertensive patients and preeclamptic patients.
  • Morbidly obese patients.
  • Spinal anesthesia contraindication as the patient refused, severe mitral or tricuspid stenosis and local sepsis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine -Al-Azhar university

Cairo, 11765, Egypt

Location

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor of anesthesia

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 18, 2023

Study Start

July 1, 2022

Primary Completion

January 1, 2023

Study Completion

February 1, 2023

Last Updated

May 22, 2023

Record last verified: 2023-05

Locations

EG(1)