NCT07838909

Brief Summary

This study aims to compare effects of ketamine versus lidocaine on postoperative cognitive dysfunction in geriatric patient undergoing hip surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

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

March 30, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
Last Updated

September 24, 2026

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

September 18, 2026

Last Update Submit

September 18, 2026

Conditions

Keywords

Hip SurgeryelderlyKetamineCognitive DysfunctionLidocaine

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative cognitive dysfunction

    3 days

Secondary Outcomes (1)

  • Postoperative pain score

    24 hours postoperatively

Study Arms (3)

Group Ketamine

EXPERIMENTAL

Patients will receive ketamine as a bolus (0.5 mg/kg) after induction of spinal anesthesia, followed by a continuous infusion (0.2 mg/kg. h) until the end of surgery.

Drug: Group Ketamine

Group Lidocaine

EXPERIMENTAL

Patients will receive lidocaine as a bolus (1.5 mg/kg) after induction of spinal anesthesia, followed by a continuous infusion (2 mg/kg. h) until the end of surgery.

Drug: Group Lidocaine

Group Placebo

PLACEBO COMPARATOR

Patients will receive placebo (saline) and administered in equal volumes and in the same manner as a control group.

Drug: Group Placebo

Interventions

Patients will receive ketamine as a bolus (0.5 mg/kg) after induction of spinal anesthesia, followed by a continuous infusion (0.2 mg/kg. h) until the end of surgery.

Group Ketamine

Patients will receive lidocaine as a bolus (1.5 mg/kg) after induction of spinal anesthesia, followed by a continuous infusion (2 mg/kg. h) until the end of surgery

Group Lidocaine

Patients will receive placebo (saline) and administered in equal volumes and in the same manner as a control group.

Group Placebo

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Both sexes of Elderly patient Aged \>65 years.
  • American Society of Anesthesiologists classification I-III.
  • Undergoing hip surgery under spinal anesthesia.

You may not qualify if:

  • Patient refusal.
  • History of mental illness or scoring less than 8 using abbreviated mental test before operation as in table 3 .
  • Obvious sinus bradycardia (heart rate of \<50 beats per minute) or other serious cardiovascular diseases.
  • Symptomatic cerebrovascular disease (such as previous stroke).
  • History of liver and kidney dysfunction.
  • Allergy to lidocaine or ketamine.
  • Metabolic disorders and fluid, electrolytes disturbances.
  • Alcohol dependence or drug abuse.
  • Redo surgery or infectious complications.
  • Central nervous system medications (antipsychotics, anticonvulsants, antiparkinsonian, antidepressants).
  • History of deep vein thrombosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 24, 2026

Study Start

March 30, 2025

Primary Completion

March 30, 2026

Study Completion

March 30, 2026

Last Updated

September 24, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

It will be available if it needed

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations