Blood pressure and spinal anaesthesia

The haemodynamic effects of spinal anaesthesia with versus without sufentanil added to bupivacaine heavy - SPINAL study: Spinal anaesthesia Investigation of Opioid anaesthesia versus Local anaesthesia

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002843-32-NL

Enrollment

Unknown

Registered

2015-09-14

Start date

2016-09-20

Completion date

Unknown

Last updated

2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient undergoing surgery for which they receive spinal anaesthesia

Interventions

Trade Name: Sufentanil Pharmaceutical Form: INN or Proposed INN: SUFENTANIL CAS Number: 56030-54-7 Trade Name: Bupivacaine heavy 0,5% Pharmaceutical Form: Solution for injection INN or Proposed INN:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing surgery with spinal anaesthesia. ASA I-III 18-90 years old Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

Exclusion criteria: - ASA IV-V - Patients younger than 18 years or older than 90 years Contra-indication for spinal anaesthesia:? ??Severe aortic valve stenosis or severe heart disease - Local infection at puncture site - Allergy for local anaesthetics or opioids

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Haemodynamic variance: percentage and number of mmHg decrease in blood pressure and mean arterial pressure (MAP), duration of decrease in blood pressure and MAP from baseline blood pressure and MAP. Baseline blood pressure and MAP: first blood pressure and MAP measured in holding area. Blood pressure and MAP decrease: lowest blood pressure and MAP registered in holding area or in the OR (percentage decrease and absolute value. Duration of decrease in blood pressure and MAP (percentage and absolute value). Amount of efedrine/fenylefrine/noradrenaline used in holding area and in the operation room. ;Timepoint(s) of evaluation of this end point: During day of surgery;Main Objective: Will spinal anaesthesia with sufentanil and bupivacaine heavy cause less hypotension compared to bupivacaine heavy alone? Will there be less use of ephedrine/fenylefrine/noradrenaline if sufentanil is added to bupivacaine heavy for spinal anaesthesia compared to bupivacaine heavy alone? ;Secondary Objective: Secondary Objective(s): What are the effects of sufentanil added to bupivacaine heavy for spinal anaesthesia on postoperative pain, pruritus, and dizziness compared to bupivacaine heavy alone?	—

Measure

Time frame

Primary end point(s): Haemodynamic variance: percentage and number of mmHg decrease in blood pressure and mean arterial pressure (MAP), duration of decrease in blood pressure and MAP from baseline blood pressure and MAP. Baseline blood pressure and MAP: first blood pressure and MAP measured in holding area. Blood pressure and MAP decrease: lowest blood pressure and MAP registered in holding area or in the OR (percentage decrease and absolute value. Duration of decrease in blood pressure and MAP (percentage and absolute value). Amount of efedrine/fenylefrine/noradrenaline used in holding area and in the operation room. ;Timepoint(s) of evaluation of this end point: During day of surgery;Main Objective: Will spinal anaesthesia with sufentanil and bupivacaine heavy cause less hypotension compared to bupivacaine heavy alone? Will there be less use of ephedrine/fenylefrine/noradrenaline if sufentanil is added to bupivacaine heavy for spinal anaesthesia compared to bupivacaine heavy alone? ;Secondary Objective: Secondary Objective(s): What are the effects of sufentanil added to bupivacaine heavy for spinal anaesthesia on postoperative pain, pruritus, and dizziness compared to bupivacaine heavy alone?

—

Secondary

Measure	Time frame
Secondary end point(s): Half hour after arrival in recovery room: Postoperative pain (NRS score) Nausea (yes/no) Vomiting (yes/no) Pruritus (yes/no) These variables will be registered by the recovery room nurse. Patients are asked to fill in the OBAS questionnaire 2 times: 1 hour and 4 hours after arrival on the ward. ;Timepoint(s) of evaluation of this end point: During day of surgery	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026