Can Different Intrathecal Drugs Affect Day Case Anal Surgery Recovery Duration?

NCT ID: NCT07156968

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-05-01

Brief Summary

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This study aims to compare effect of adding fentanyl or dexmetomidine on duration of motor and sensory block after spinal anesthesia with prilocaine during day case perianal surgery and whether it impact time to discharge home.

Detailed Description

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Conditions

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Effect of Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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The bupivacaine-fentanyl group

Group Type EXPERIMENTAL

Bupivacaine-fentanyl

Intervention Type DRUG

A peripheral intravenous (IV) catheter will be inserted, and a 7 mL kg-1 crystalloid infusion will be initiated. The patients will be premedicated with 0.03 mg kg-1 midazolam IV. Heart rate and peripheral oxygen saturation (SpO2) will be monitored continuously; systolic, diastolic, and mean arterial pressure (MAP) will be measured noninvasively at 5 min intervals during the procedure and at 15 min intervals during the post anesthesia care unit (PACU) stay. The baseline values will be recorded. Nasal oxygen 2 L min-1 will be administered during the whole procedure

The prilocaine-fentanyl group

Group Type EXPERIMENTAL

Bupivacaine-fentanyl

Intervention Type DRUG

A peripheral intravenous (IV) catheter will be inserted, and a 7 mL kg-1 crystalloid infusion will be initiated. The patients will be premedicated with 0.03 mg kg-1 midazolam IV. Heart rate and peripheral oxygen saturation (SpO2) will be monitored continuously; systolic, diastolic, and mean arterial pressure (MAP) will be measured noninvasively at 5 min intervals during the procedure and at 15 min intervals during the post anesthesia care unit (PACU) stay. The baseline values will be recorded. Nasal oxygen 2 L min-1 will be administered during the whole procedure

The prilocaine-dexametomidine group

Group Type EXPERIMENTAL

Bupivacaine-fentanyl

Intervention Type DRUG

A peripheral intravenous (IV) catheter will be inserted, and a 7 mL kg-1 crystalloid infusion will be initiated. The patients will be premedicated with 0.03 mg kg-1 midazolam IV. Heart rate and peripheral oxygen saturation (SpO2) will be monitored continuously; systolic, diastolic, and mean arterial pressure (MAP) will be measured noninvasively at 5 min intervals during the procedure and at 15 min intervals during the post anesthesia care unit (PACU) stay. The baseline values will be recorded. Nasal oxygen 2 L min-1 will be administered during the whole procedure

Interventions

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Bupivacaine-fentanyl

A peripheral intravenous (IV) catheter will be inserted, and a 7 mL kg-1 crystalloid infusion will be initiated. The patients will be premedicated with 0.03 mg kg-1 midazolam IV. Heart rate and peripheral oxygen saturation (SpO2) will be monitored continuously; systolic, diastolic, and mean arterial pressure (MAP) will be measured noninvasively at 5 min intervals during the procedure and at 15 min intervals during the post anesthesia care unit (PACU) stay. The baseline values will be recorded. Nasal oxygen 2 L min-1 will be administered during the whole procedure

Intervention Type DRUG

Other Intervention Names

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prilocaine-fentanyl prilocaine-dexametomidine

Eligibility Criteria

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Inclusion Criteria

* Ages 18-70
* ASA 1-3
* height \<155cm or \>175cm
* Day case perianal surgery

Exclusion Criteria

* Hypersensitivity to the study drugs
* Refusal of patients.
* Patients with contraindications for spinal anesthesia
* previous voiding difficulty
* patients taking anticholinergic medications.
* emergency cases
* Patients with contraindications for day case sitting.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Nasser Sayed

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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R 138 / 2021

Identifier Type: -

Identifier Source: org_study_id

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